Cleared Traditional

FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN

K000054 · Adri · General & Plastic Surgery

Mar 2000

Decision

66d

Days

—

Risk

About This 510(k) Submission

K000054 is an FDA 510(k) clearance for the FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN, a Wound Dressing With Animal-derived Material(s), submitted by Adri (Park Forest, US). The FDA issued a Cleared decision on March 13, 2000, 66 days after receiving the submission on January 7, 2000. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K000054 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 07, 2000
Decision Date	March 13, 2000
Days to Decision	66 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement