Cleared Traditional

K132343 - MARIGEN WOUND DRESSING (FDA 510(k) Clearance)

K132343 · Kerecis Limited · General & Plastic Surgery device

Oct 2013

Decision

85d

Days

Risk

K132343 is an FDA 510(k) clearance for the MARIGEN WOUND DRESSING. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Kerecis Limited (Isafjordur, IS). The FDA issued a Cleared decision on October 23, 2013, 85 days after receiving the submission on July 30, 2013.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K132343 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 30, 2013
Decision Date	October 23, 2013
Days to Decision	85 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF