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510(k) K915150

REMOVE ADHESIVE REMOVER by Smith & Nephew United, Inc. — Product Code KOX

K915150 is an FDA 510(k) premarket notification submitted by Smith & Nephew United, Inc. for the device "REMOVE ADHESIVE REMOVER". The FDA issued a decision of Substantially Equivalent on January 9, 1992. The device falls under product code KOX (Solvent, Adhesive Tape), a Class I device regulated under 21 CFR 878.4730. Smith & Nephew United, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1992
Date Received
November 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solvent, Adhesive Tape
Device Class
Class I
Regulation Number
878.4730
Review Panel
SU
Submission Type

Other clearances by Smith & Nephew United, Inc.

  • K963096 — ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING (October 25, 1996)
  • K961775 — PROFORE FOUR-LAYER BANDAGE SYSTEM KIT (July 16, 1996)
  • K945330 — ALLEVYN ADHESIVE (February 9, 1995)
  • K943619 — CAVI-CARE CONFORMING FOAM DRESSING (August 19, 1994)
  • K942748 — INTRASITE (June 29, 1994)
  • K935705 — ALLEVYN ISLAND WOUND DRESSING (February 15, 1994)
  • K935803 — CICA-CARE SILICONE GEL SHEET (February 3, 1994)
  • K932263 — SOLOSITE DERMAL WOUND GEL (October 1, 1993)
  • K926508 — INTRASITE GEL (July 13, 1993)
  • K922897 — STRAPPAL (September 15, 1992)

Other clearances for product code KOX

  • K934790 — SEPP ADHESIVE REMOVER (March 11, 1994)
  • K931933 — CHAD LABS ADHESIVE BANDAGE REMOVER (July 8, 1993)
  • K924976 — ALLKARE(TM) ADHESIVE REMOVER WIPE (April 20, 1993)
  • K924571 — MEDI-SOL (April 6, 1993)
  • K925618 — 3M REMOVER LOTION PRODUCT NUMBER 86XX (March 31, 1993)
  • K923351 — SKIN SUPPORT PREP PAD (September 14, 1992)
  • K902009 — ELANTEC'S SURGICAL TAPE REMOVER (August 29, 1990)
  • K895293 — KEMI LABS - ADHESIVE BANDAGE REMOVER (February 9, 1990)
  • K893603 — REMOVE ADHESIVE REMOVER (July 14, 1989)
  • K881359 — DECALCIFYING SOLUTION II (April 19, 1988)

FDA data resources