Cleared Traditional

Collagen Dental Wound Dressings

K152600 · Collagen Matrix, Inc. · General & Plastic Surgery
Jun 2016
Decision
286d
Days
Risk

About This 510(k) Submission

K152600 is an FDA 510(k) clearance for the Collagen Dental Wound Dressings, a Wound Dressing With Animal-derived Material(s), submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on June 23, 2016, 286 days after receiving the submission on September 11, 2015. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K152600 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2015
Decision Date June 23, 2016
Days to Decision 286 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KGN — Wound Dressing With Animal-derived Material(s)
Device Class