Home / 510(k) Clearances / K896358

510(k) K896358

VARI/MOIST WOUND DRESSING by Catalina Biomedical Corp. — Product Code KGX

K896358 is an FDA 510(k) premarket notification submitted by Catalina Biomedical Corp. for the device "VARI/MOIST WOUND DRESSING". The FDA issued a decision of SN 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. Catalina Biomedical Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
February 1, 1990
Date Received
November 6, 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 Catalina Biomedical Corp.

  • K920050 — BIOLEX WOUND GEL, (April 7, 1992)
  • K913480 — WOUND CARE TRAY A (October 18, 1991)
  • K913479 — WOUND CARE TRAY B (October 8, 1991)
  • K896421 — TRANSPARENT FILM I.V. SITE/WOUND DRESSING (January 31, 1990)

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