OXYBAND WOUND DRESSING

Dressing, Wound, Drug

O2S, LLC

The following data is part of a premarket notification filed by O2s, Llc with the FDA for Oxyband Wound Dressing.

Pre-market Notification Details

• Device ID: K121407
• 510k Number: K121407
• Device Name: OXYBAND WOUND DRESSING
• Classification: Dressing, Wound, Drug
• Applicant: O2S, LLC 1500 SPRING GARDEN ST Philadelphia, PA 19130
• Contact: David E Petko, P.e.
• Correspondent: David E Petko, P.e.; O2S, LLC 1500 SPRING GARDEN ST Philadelphia, PA 19130
• 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: 2012-05-10
• Decision Date: 2012-07-09
• Summary: summary