MicroMatrix

Dressing, Wound, Collagen

ACell, Inc.

The following data is part of a premarket notification filed by Acell, Inc. with the FDA for Micromatrix.

Pre-market Notification Details

• Device ID: K172399
• 510k Number: K172399
• Device Name: MicroMatrix
• Classification: Dressing, Wound, Collagen
• Applicant: ACell, Inc. 6640 Eli Whitney Drive, Suite 200 Columbia, MD 21046
• Contact: Salman Elmi
• Correspondent: John Smith; Hogan Lovells 555 Thirteenth Street., NW Washington, DC 20004
• Product Code: KGN
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-08
• Decision Date: 2017-10-06
• Summary: summary