Cleared Traditional

K111524 - MP 719
(FDA 510(k) Clearance)

K111524 · Marine Polymer Technologies, Inc. · General & Plastic Surgery device

Jul 2011

Decision

50d

Days

—

Risk

K111524 is an FDA 510(k) clearance for the MP 719. This device is classified as a Wax, Bone.

Submitted by Marine Polymer Technologies, Inc. (Danvers, US). The FDA issued a Cleared decision on July 22, 2011, 50 days after receiving the submission on June 2, 2011.

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

Submission Details

510(k) Number	K111524 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 02, 2011
Decision Date	July 22, 2011
Days to Decision	50 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF