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: K153754
• 510k Number: K153754
• Device Name: MicroMatrix
• Classification: Dressing, Wound, Collagen
• Applicant: ACELL, INC 6640 ELI WHITNEY DRIVE Columbia, MD 21046
• Contact: Thomas Gilbert
• Correspondent: John Smith; HOGAN LOVELLS 555 13TH ST., NW Washington, DC 20004
• Product Code: KGN
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-12-29
• Decision Date: 2016-03-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00386190001202	K153754	000
00386190000014	K153754	000
00386190000137	K153754	000
00386190000151	K153754	000
00386190000168	K153754	000
00386190000182	K153754	000
00386190000199	K153754	000
00386190000212	K153754	000
00386190000229	K153754	000
00386190001127	K153754	000
00386190001134	K153754	000
00386190001141	K153754	000
00386190001158	K153754	000
00386190001165	K153754	000
00386190001172	K153754	000
00386190001189	K153754	000
00386190001196	K153754	000
00386190000007	K153754	000