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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 K120782
Device Name INTERVENTIONAL HEMOSTATIC BANDAGE
Applicant
Z-MEDICA CORPORATION
4 fairfield blvd.
wallingford,  CT  06492
Contact sheila wallin
Classification Product Code
FRO  
Date Received03/16/2012
Decision Date 03/20/2013
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 No
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