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510(k) K944587

DERMIVIEW HYPOALLERGENIC CLEAR TAPE by Johnson & Johnson Medical, Inc. — Product Code KGX

K944587 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Medical, Inc. for the device "DERMIVIEW HYPOALLERGENIC CLEAR TAPE". The FDA issued a decision of Substantially Equivalent on October 30, 1995. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Johnson & Johnson Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1995
Date Received
September 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 Medical, Inc.

  • K033523 — COLLAGEN-ORC ANTIMICROBIAL MATRIX (October 21, 2004)
  • K022483 — ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING (February 3, 2003)
  • K014129 — PROMOGRAN MATRIX WOUND DRESSING (February 14, 2002)
  • K001690 — PROTECTIV SAFETY BLOOD COLLECTION NEEDLE (July 31, 2000)
  • K982641 — ADVANCED NIBP MODULE (March 29, 1999)
  • K983362 — NU-GEL * WOUND DRESSING (December 16, 1998)
  • K982597 — FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE (August 20, 1998)
  • K974080 — CRITIKON SOFT BLOOD PRESSURE CUFF (May 18, 1998)
  • K980493 — I.V. CATHETER SYSTEM (April 28, 1998)
  • K972498 — OBSERVER * CENTRAL STATION (February 17, 1998)

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)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)
  • K940798 — SHIPPERT PRESSURE BANDAGE (September 28, 1994)

FDA data resources