Cleared Traditional

Talymed Suspension

K160695 · Marine Polymer Technologies, Inc. · General & Plastic Surgery
Dec 2016
Decision
267d
Days
Risk

About This 510(k) Submission

K160695 is an FDA 510(k) clearance for the Talymed Suspension, a Dressing, Wound, Drug, submitted by Marine Polymer Technologies, Inc. (Danvers, US). The FDA issued a Cleared decision on December 6, 2016, 267 days after receiving the submission on March 14, 2016. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K160695 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2016
Decision Date December 06, 2016
Days to Decision 267 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class

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