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510(k) K883250

STERI-CLENS WOUND CARE KIT by Absorbent Cotton Co., Inc. — Product Code LRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1988
Date Received
August 2, 1988
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 Absorbent Cotton Co., Inc.

  • K880613 — ACCO(R) FACE MASK (March 4, 1988)
  • K875129 — STERI-CLENS (February 18, 1988)
  • K874741 — STERI-CLENS(TM) SURGICAL SCRUB SPONGE (December 10, 1987)
  • K873523 — PLAIN DRY GAUZE (October 9, 1987)
  • K854740 — PRIMADERM (March 14, 1986)
  • K850126 — OIL EMULSION NON-ADHERING DRESSING (April 25, 1985)
  • K844095 — WET DRESSING WATER-STERILE (November 27, 1984)
  • K844096 — WET DRESSING SALINE-STERILE (November 19, 1984)
  • K781727 — CHANGE IN STERILIZATION PROCEDURE (December 4, 1978)

Other clearances for product code LRO

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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)