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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
Applicant
HOYA CORPORATION
5600 wisconsin avenue
#509
chevy chase,  MD  20815
Contact patsy j trisler
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/28/2012
Decision Date 03/23/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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