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510(k) K896733

VACCON by Unoplast A/S — Product Code KGX

K896733 is an FDA 510(k) premarket notification submitted by Unoplast A/S for the device "VACCON". The FDA issued a decision of Substantially Equivalent on February 1, 1990. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Unoplast A/S has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1990
Date Received
November 30, 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 Unoplast A/S

  • K896734 — FEEDING TUBE (December 21, 1990)
  • K896729 — NELATON-, FEMALE - OR TIEMANN CATHETER (November 5, 1990)
  • K896732 — UNOMETER 500 (November 2, 1990)
  • K896731 — OXYGEN CATHETERS (March 30, 1990)
  • K896730 — SUCTION CATHETER STRAIGHT/COUDE (March 30, 1990)
  • K802248 — DISARP ORIGINAL (September 26, 1980)

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