Cleared Special

BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES

K120828 · Coloplast A/S · General & Plastic Surgery

Apr 2012

Decision

17d

Days

—

Risk

About This 510(k) Submission

K120828 is an FDA 510(k) clearance for the BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES, a Dressing, Wound, Drug, submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on April 5, 2012, 17 days after receiving the submission on March 19, 2012. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K120828 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 19, 2012
Decision Date	April 05, 2012
Days to Decision	17 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF