Cleared Traditional

FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE

K982597 · Johnson & Johnson Medical, Inc. · General & Plastic Surgery

Aug 1998

Decision

27d

Days

—

Risk

About This 510(k) Submission

K982597 is an FDA 510(k) clearance for the FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE, a Wound Dressing With Animal-derived Material(s), submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on August 20, 1998, 27 days after receiving the submission on July 24, 1998. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K982597 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 1998
Decision Date	August 20, 1998
Days to Decision	27 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF