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510(k) K910436

ELASTIC ADHESIVE BANDAGE by Byron Medical — Product Code KGX

K910436 is an FDA 510(k) premarket notification submitted by Byron Medical for the device "ELASTIC ADHESIVE BANDAGE". The FDA issued a decision of Substantially Equivalent on March 19, 1991. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Byron Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1991
Date Received
January 31, 1991
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 Byron Medical

  • K040149 — PSI-TEC PERISTALTIC INFILTRATION PUMP (June 3, 2004)
  • K001803 — ACCELERATOR RECIPROCATING CANNULA (August 4, 2000)
  • K981215 — PSI-TEC LIPOSUCTION ASPIRATOR (July 1, 1998)
  • K981172 — LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES (June 30, 1998)
  • K980738 — PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILT (June 16, 1998)
  • K980392 — PSI-TEC ASPIRATOR (March 5, 1998)
  • K974295 — BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (February 10, 1998)
  • K973133 — BIG BAG 3000 PRESSURE INFUSOR (September 12, 1997)
  • K934179 — DISPOSABLE BAG DECANTER (May 23, 1994)
  • K934233 — ZARA ZONE IV MALAR IMPLANT MODIFICATION (February 3, 1994)

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)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)

FDA data resources