Cleared Special

K040211 - MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING (FDA 510(k) Clearance)

K040211 · Collagen Matrix, Inc. · General & Plastic Surgery device

Feb 2004

Decision

28d

Days

—

Risk

K040211 is an FDA 510(k) clearance for the MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Collagen Matrix, Inc. (Franklin Lakes, US). The FDA issued a Cleared decision on February 27, 2004, 28 days after receiving the submission on January 30, 2004.

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

Submission Details

510(k) Number	K040211 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 30, 2004
Decision Date	February 27, 2004
Days to Decision	28 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF