Cleared Traditional

K012990 - COLLATEK POWDER
(FDA 510(k) Clearance)

K012990 · Biocore Medical Technologies, Inc. · General & Plastic Surgery device

Oct 2001

Decision

48d

Days

—

Risk

K012990 is an FDA 510(k) clearance for the COLLATEK POWDER. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Biocore Medical Technologies, Inc. (Silver Spring, US). The FDA issued a Cleared decision on October 24, 2001, 48 days after receiving the submission on September 6, 2001.

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

Submission Details

510(k) Number	K012990 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 06, 2001
Decision Date	October 24, 2001
Days to Decision	48 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF