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510(k) K972914

SYVEK PATCH by Marine Polymer Technologies, Inc. — Product Code KGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1997
Date Received
August 7, 1997
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 Marine Polymer Technologies, Inc.

  • K160695 — Talymed Suspension (December 6, 2016)
  • K132293 — SYVEK RADIAL BAND (July 31, 2014)
  • K111524 — MP 719 (July 22, 2011)
  • K102002 — TALYMED (July 28, 2010)
  • K082703 — MRDH BANDAGE (October 14, 2008)
  • K070557 — MP 719 (May 23, 2007)
  • K053300 — SYVEKEXCEL (March 28, 2006)
  • K002550 — RDH BANDAGE (December 20, 2000)
  • K984177 — MODIFICATION TO SKVEKPATCH (December 18, 1998)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • 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)
  • K940798 — SHIPPERT PRESSURE BANDAGE (September 28, 1994)