SilverSeal

Dressing, Wound, Drug

Alliqua BioMedical, Inc

The following data is part of a premarket notification filed by Alliqua Biomedical, Inc with the FDA for Silverseal.

Pre-market Notification Details

• Device ID: K171041
• 510k Number: K171041
• Device Name: SilverSeal
• Classification: Dressing, Wound, Drug
• Applicant: Alliqua BioMedical, Inc 2150 Cabot Boulevard West Suite B Langhorne, PA 19047
• Contact: Johanna Reinert
• Correspondent: Johanna Reinert; Alliqua BioMedical, Inc 2150 Cabot Boulevard West Suite B Langhorne, PA 19047
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2017-04-07
• Decision Date: 2017-08-22
• Summary: summary