MatriDerm

Dressing, Wound, Collagen

MedSkin Solutions Dr. Suwelack AG

The following data is part of a premarket notification filed by Medskin Solutions Dr. Suwelack Ag with the FDA for Matriderm.

Pre-market Notification Details

• Device ID: K201577
• 510k Number: K201577
• Device Name: MatriDerm
• Classification: Dressing, Wound, Collagen
• Applicant: MedSkin Solutions Dr. Suwelack AG Josef-Suwelack-Strasse 2 Billerbeck, DE 48727
• Contact: Zuzana Hülsbusch
• Correspondent: Zuzana Hülsbusch; MedSkin Solutions Dr. Suwelack AG Josef-Suwelack-Strasse 2 Billerbeck, DE 48727
• 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: 2020-06-11
• Decision Date: 2021-01-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04250569301780	K201577	000
04250569301773	K201577	000
04250569301766	K201577	000
04250569301759	K201577	000
04250569301742	K201577	000
04250569301735	K201577	000