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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 K062459
Device Name ORIGEN DBM WITH BIOACTIVE GLASS
Applicant
Nanotherapeutics
12337 NW 9th Lane
Newberry,  FL  32669
Applicant Contact PAULA WILKERSON
Correspondent
Nanotherapeutics
12337 NW 9th Lane
Newberry,  FL  32669
Correspondent Contact PAULA WILKERSON
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
MBP  
Date Received08/23/2006
Decision Date 02/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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