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: K193085
• 510k Number: K193085
• Device Name: PuraDERM Gel
• Classification: Dressing, Wound, Drug
• Applicant: 3-D Matrix, Inc. 250 First Ave., Suite 205 Needham, MA 02494
• Contact: Lisa Spirio
• Correspondent: Stephen P. Rhodes; Streamline Regulatory 3502 Dundee Driveway Chevy Chase, MD 20815
• 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: 2019-11-05
• Decision Date: 2020-05-11