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510(k) K931844

CUSTOM PROCEDURE MEDICAL TRAY OR KIT by Custom Medical Products, Ltd. — Product Code LRO

K931844 is an FDA 510(k) premarket notification submitted by Custom Medical Products, Ltd. for the device "CUSTOM PROCEDURE MEDICAL TRAY OR KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on January 25, 1994. The device falls under product code LRO (General Surgery Tray), a Class II device regulated under 21 CFR 878.4370. Custom Medical Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
January 25, 1994
Date Received
April 13, 1993
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 Custom Medical Products, Ltd.

  • K994199 — VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCED (June 9, 2000)
  • K931417 — STERILE EQUIPMENT COVERS (July 6, 1995)
  • K931456 — SURGICAL DRAPE AND GOWN TRAY (July 8, 1994)
  • K930815 — ABDOMINAL / THORACIC PATIENT DRAPE (May 5, 1994)
  • K931418 — SURGICAL DRAPE (May 5, 1994)
  • K931455 — HEAD SHEET (May 5, 1994)
  • K926519 — SURGICAL GOWN (August 12, 1993)
  • K900848 — ENEMA KIT 'STRAIGHT' DESIGN (April 13, 1990)
  • K900847 — ENEMA KIT 'Y' DESIGN (April 13, 1990)
  • K895084 — APERTURE (October 27, 1989)

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