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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wax,bone
510(K) Number K121953
Device Name HEMASORB APPLY
Applicant
ORTHOCON, INC.
1 bridge st ste 121
irvington,  NY  10533
Contact richard kronenthal, phd
Classification Product Code
MTJ  
Date Received07/03/2012
Decision Date 11/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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