PROWICK

Dressing, Wound, Drug

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Prowick.

Pre-market Notification Details

• Device ID: K083007
• 510k Number: K083007
• Device Name: PROWICK
• Classification: Dressing, Wound, Drug
• Applicant: ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945
• Contact: Sally Foust
• Correspondent: Sally Foust; ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2008-10-08
• Decision Date: 2009-04-08
• Summary: summary