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510(k) K922897

STRAPPAL by Smith & Nephew United, Inc. — Product Code KGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1992
Date Received
June 16, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

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  • 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)
  • K914147 — ALLEVLYN WOUND DRESSING, MODIFICATION (February 3, 1992)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • K972914 — SYVEK PATCH (December 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K952606 — TARGETT PATCH (December 21, 1995)
  • K954007 — PARALLEL (November 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (October 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)