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510(k) K890098

KLEEN TEST O.R. KIT by Kleen Test Products — Product Code LRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1989
Date Received
January 10, 1989
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 Kleen Test Products

  • K890039 — KLEEN TEST BASIN SET (October 24, 1989)
  • K890539 — SURE COUNT LIGHT HANDLE COVER (February 27, 1989)
  • K853622 — SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030 (October 10, 1985)
  • K853454 — SURE COUNT 5 & 10 SPONGE COUNTER (September 5, 1985)
  • K853315 — CAUTERY TIP CLEANING PAD (August 21, 1985)
  • K852258 — SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER (June 27, 1985)
  • K852257 — SURE-COUNT 15 COUNT NEEDLE COUNTER (June 26, 1985)
  • K844199 — ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET (November 7, 1984)
  • K821396 — OUT-RITE WASTE DISPOSABLE BAG (June 9, 1982)
  • K821394 — SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER (June 3, 1982)

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)