510(k) K874760

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

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.

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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)

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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)