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510(k) K874760

CK 4900 SERIES, GOWN AND TOWEL PAK by Currie Medical Specialties, Inc. — Product Code LRO

K874760 is an FDA 510(k) premarket notification submitted by Currie Medical Specialties, Inc. for the device "CK 4900 SERIES, GOWN AND TOWEL PAK". The FDA issued a decision of Substantially Equivalent on December 10, 1987. The device falls under product code LRO (General Surgery Tray), a Class II device regulated under 21 CFR 878.4370. Currie Medical Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1987
Date Received
November 19, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
General Surgery Tray
Device Class
Class II
Regulation Number
878.4370
Review Panel
SU
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance

Other clearances by Currie Medical Specialties, Inc.

  • K151158 — ALP VasQcare Take Home System (December 10, 2015)
  • K143317 — Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) (January 20, 2015)
  • K140092 — CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES) (April 16, 2014)
  • K112311 — ALP 501 RB PUMP SYSTEM (September 1, 2011)
  • K902441 — DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS) (August 23, 1990)
  • K872395 — CK 1600 SERIES, TOWELS (July 2, 1987)
  • K871737 — CK 7000 SERIES 5 IN 1 CONNECTOR AND Y-CONNECTOR (June 22, 1987)
  • K864816 — CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGE (January 8, 1987)
  • K864697 — CK 6000 SERIES, TOWELS (December 18, 1986)
  • K834558 — CK10000 SERIES POUCH & BAGS ETC. (September 5, 1984)

Other clearances for product code LRO

  • K213481 — Medline General Surgery Tray (May 24, 2022)
  • K212258 — Medline Cardiovascular Procedure Kit (December 3, 2021)
  • K041080 — SURGICAL DRAPE KIT - D.I.R.R.A. SRL (November 30, 2004)
  • K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (March 31, 2003)
  • K023276 — AMSINO TRACHEOSTOMY CARE TRAY (December 9, 2002)
  • K980137 — WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY (January 30, 1998)
  • K971061 — OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (June 11, 1997)
  • K971062 — OPPORTUNITY INC. GENERAL PURPOSE TRAY (June 9, 1997)
  • K932221 — NEUROLOGICAL OR CRANI TRAYS (PACKS) (March 19, 1997)
  • K970286 — PRESBYTERIAN LINEN SERVICES SURGICAL PACKS (March 10, 1997)

FDA data resources