PuraDerm Gel

Dressing, Wound, Drug

3-D Matrix, Inc.

The following data is part of a premarket notification filed by 3-d Matrix, Inc. with the FDA for Puraderm Gel.

Pre-market Notification Details

• Device ID: K143058
• 510k Number: K143058
• Device Name: PuraDerm Gel
• Classification: Dressing, Wound, Drug
• Applicant: 3-D Matrix, Inc. 200 West St. Ste 14 Waltham, MA 02451
• Contact: Lisa Spirio
• Correspondent: Denise Gottfried; TekTeam, LLC 2225 E. Bayshore Rd. Palo Alto, CA 94303
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-10-24
• Decision Date: 2015-02-13
• Summary: summary