OXYBAND WOUND DRESSING

Dressing, Wound, Drug

OXYBAND TECHNOLOGIES, INC.

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

Pre-market Notification Details

• Device ID: K043063
• 510k Number: K043063
• Device Name: OXYBAND WOUND DRESSING
• Classification: Dressing, Wound, Drug
• Applicant: OXYBAND TECHNOLOGIES, INC. 5 TIMBER LANE North Reading, MA 01864
• Contact: Maureen O'connell
• Correspondent: Maureen O'connell; OXYBAND TECHNOLOGIES, INC. 5 TIMBER LANE North Reading, MA 01864
• 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: 2004-11-05
• Decision Date: 2005-03-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00009235421772	K043063	000
00009235000007	K043063	000