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510(k) K901856

CUSTOM WOUND MANAGEMENT KITS AND TRAYS by Medcare Custom Packaging, Inc. — Product Code LRO

K901856 is an FDA 510(k) premarket notification submitted by Medcare Custom Packaging, Inc. for the device "CUSTOM WOUND MANAGEMENT KITS AND TRAYS". The FDA issued a decision of Substantially Equivalent (with conditions) on August 1, 1990. The device falls under product code LRO (General Surgery Tray), a Class II device regulated under 21 CFR 878.4370. Medcare Custom Packaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
August 1, 1990
Date Received
April 24, 1990
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 Medcare Custom Packaging, Inc.

  • K954869 — MEDCARE YANKAUER SUCTION DEVICE (January 19, 1996)
  • K954442 — STERILE ISOTONIC SALINE & STERILE WATER (December 21, 1995)
  • K952759 — TOWEL PACK (September 29, 1995)
  • K950390 — URETHRAL CATHETERIZATION TRAY (May 30, 1995)
  • K943661 — STERILE PHYSIOLOGICAL SALINE/STERILE WATER (April 10, 1995)
  • K951149 — SINGLE USE INSTRUMENT TRAY (April 6, 1995)
  • K934732 — PELVIC EXAM TRAY (December 30, 1994)
  • K942000 — BURN DRESSING TRAY (May 20, 1994)
  • K936261 — CATHETER INSERTION TRAY (March 10, 1994)
  • K922179 — CATHETER INSERTION TRAY (July 2, 1993)

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