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510(k) K896455

VITACHOICE WOUND DRESSING by Vitaphore Corp. — Product Code KGX

K896455 is an FDA 510(k) premarket notification submitted by Vitaphore Corp. for the device "VITACHOICE WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on February 15, 1990. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Vitaphore Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1990
Date Received
November 9, 1989
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 Vitaphore Corp.

  • K914579 — SILVER FOAM WOUND DRESSING (February 21, 1992)
  • K913148 — COLLAGEN SHIELD FOR ACUTE CARE (October 15, 1991)
  • K895920 — VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS (June 6, 1991)
  • K902558 — COLLAGEN SHIELD FOR ACUTE CARE (August 17, 1990)
  • K891993 — COLLAGEN NEUROSPONGE (March 23, 1990)
  • K896046 — VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE (January 11, 1990)
  • K895993 — VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE (January 11, 1990)
  • K890435 — VITAACCESS CATHETER INTRODUCER KIT (March 29, 1989)
  • K882100 — VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT (July 13, 1988)
  • K872998 — VITAACCESS (TM) CATHETER INTRODUCER SYSTEM (March 24, 1988)

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