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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 K110976
Device Name ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM
Applicant
Nanotherapeutics, Inc.
13859 Progress Blvd. Suite 300
Alachua,  FL  32615
Applicant Contact DENNIS TOMISAKA
Correspondent
Nanotherapeutics, Inc.
13859 Progress Blvd. Suite 300
Alachua,  FL  32615
Correspondent Contact DENNIS TOMISAKA
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
MBP  
Date Received04/07/2011
Decision Date 05/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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