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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
Original Applicant
O2S, LLC
1500 spring garden st
philadelphia,  PA  19130
Original Contact david e petko, p.e.
Classification Product Code
FRO  
Date Received05/10/2012
Decision Date 07/09/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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