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510(k) K963443

PROD. NO. 02-031 - LACERATION TRAY by Continental Medical Laboratories, Inc. — Product Code LRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1996
Date Received
August 30, 1996
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 Continental Medical Laboratories, Inc.

  • K964827 — PROD. NO. 01-132 - SUTURE REMOVAL KIT (February 14, 1997)
  • K963234 — STAPLE REMOVAL KIT (October 21, 1996)
  • K962078 — TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER (October 11, 1996)
  • K954728 — PROD NO. 01-1694 - 4X4 FOAM DRESSING (September 23, 1996)
  • K962073 — URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY (June 21, 1996)
  • K952335 — WOUND CARE MANAGEMENT KITS (June 14, 1995)
  • K905123 — G-TUBE DRESSING CHANGE TRAY (March 27, 1991)

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  • 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)