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510(k) K942383

DERMIVIEW CLEAR TAPE by Johnson & Johnson International — Product Code KGX

K942383 is an FDA 510(k) premarket notification submitted by Johnson & Johnson International for the device "DERMIVIEW CLEAR TAPE". The FDA issued a decision of Substantially Equivalent on August 22, 1994. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Johnson & Johnson International has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1994
Date Received
May 19, 1994
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

Other clearances by Johnson & Johnson International

  • K965198 — ULTIMA TPS CEMENTED STEM (July 23, 1997)
  • K944937 — SYNTHETIC ABSORBABLE SUTURE (May 19, 1995)
  • K946245 — TIELLE* HYDROPOLYMER DRESSING (April 11, 1995)
  • K922918 — BARRIER SAF-TE HYDROGEL DRAPE (July 6, 1993)
  • K923807 — P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS (November 9, 1992)
  • K896828 — BIOCLUSIVE(R) ABSORBENT DRESSING (November 21, 1990)
  • K901456 — ORTHOSORB(R) ABSORBABLE PIN (August 15, 1990)
  • K900638 — P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT (April 30, 1990)
  • K895207 — BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM (September 28, 1989)

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)

FDA data resources