510(k) K901856

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

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)