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510(k) K802764

PLASTIC ADHESIVE BANDAGE by Dyn-A-Med Products — Product Code KGX

K802764 is an FDA 510(k) premarket notification submitted by Dyn-A-Med Products for the device "PLASTIC ADHESIVE BANDAGE". The FDA issued a decision of Substantially Equivalent on November 24, 1980. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Dyn-A-Med Products has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1980
Date Received
November 4, 1980
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 Dyn-A-Med Products

  • K844121 — CLAMP, TUBING, LINE (December 17, 1984)
  • K813176 — GEL ELECTRODE (December 29, 1981)
  • K811157 — BLADE, TONGUE (May 27, 1981)
  • K802139 — SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY (October 31, 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)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)

FDA data resources