FDA 510(k), K043063, OXYBAND WOUND DRESSING

510(K) Number: K043063
Device Name: OXYBAND WOUND DRESSING
Manufacturer: MAUREEN O'CONNELL
Device Classification Name: Dressing, Wound, Drug
Regulation Number: FRO
Classification Product Code: KXA
Date Received: 11/05/2004
Decision Date: 03/24/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery

Total number of pages: 1,697
Fully redacted pages: 1,605
Content pages: 92