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510(k) K821490

SILKAFIX ADHESIVE PLASTER by Selomas, Inc. — Product Code KGX

K821490 is an FDA 510(k) premarket notification submitted by Selomas, Inc. for the device "SILKAFIX ADHESIVE PLASTER". The FDA issued a decision of Substantially Equivalent on June 2, 1982. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Selomas, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1982
Date Received
May 18, 1982
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 Selomas, Inc.

  • K861215 — GAUZE SPONGES USP TYPE VII (April 17, 1986)
  • K821258 — SELOPOR (August 19, 1982)
  • K821260 — VITOFIT (June 23, 1982)
  • K821259 — VITASAN (June 23, 1982)
  • K821257 — SELOFIX (May 14, 1982)
  • K812501 — OPRAFLEX (October 2, 1981)

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