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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, calcium compound
510(k) Number K120602
Device Name APACERAM BONE GRAFT SUBSTITUTE
Original Applicant
HOYA CORPORATION
5600 wisconsin avenue
#509
chevy chase,  MD  20815
Original Contact patsy j trisler
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/28/2012
Decision Date 03/23/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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