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510(k) K160695

Talymed Suspension by Marine Polymer Technologies, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2016
Date Received
March 14, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Marine Polymer Technologies, Inc.

  • 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)
  • K972914 — SYVEK PATCH (December 22, 1997)

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