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510(k) K983368

CARE BAND ANTIBACTERIAL BANDAGES by Aso Corp. — Product Code KGX

K983368 is an FDA 510(k) premarket notification submitted by Aso Corp. for the device "CARE BAND ANTIBACTERIAL BANDAGES". The FDA issued a decision of Substantially Equivalent on February 17, 1999. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Aso Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1999
Date Received
September 24, 1998
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 Aso Corp.

  • K082910 — CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES (June 17, 2009)
  • K933159 — XYZ PADS (December 13, 1993)
  • K932602 — ADHESIVE BANDAGES (August 9, 1993)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • 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)
  • 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