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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name filler, bone void, osteoinduction (w/o human growth factor)
510(k) Number K113728
Device Name SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
Original Applicant
HANS BIOMED CORP.
5600 wisconsin avenue #509
chevy chase,  MD  20815
Original Contact patsy j trisler
Regulation Number888.3045
Classification Product Code
MBP  
Subsequent Product Code
MQV  
Date Received12/19/2011
Decision Date 11/15/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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