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510(k) K160695

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

K160695 is an FDA 510(k) premarket notification submitted by Marine Polymer Technologies, Inc. for the device "Talymed Suspension". The FDA issued a decision of Substantially Equivalent on December 6, 2016. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Marine Polymer Technologies, Inc. has at least 9 other 510(k) clearances on record.

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)

Other clearances for product code FRO

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources