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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K121407
Device Name OXYBAND WOUND DRESSING
Applicant
O2s, LLC
1500 Spring Garden St.
Philadelphia,  PA  19130
Applicant Contact DAVID E PETKO, P.E.
Correspondent
O2s, LLC
1500 Spring Garden St.
Philadelphia,  PA  19130
Correspondent Contact DAVID E PETKO, P.E.
Classification Product Code
FRO  
Date Received05/10/2012
Decision Date 07/09/2012
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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