FDA 510(k) Application Details - K060285

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K060285
Device Name Bone Grafting Material, Synthetic
Applicant BIO-LOK INTL., INC.
505 MORRIS AVENUE, SUITE 104
SPRINGFIELD, NJ 07081 US
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Contact HAROLD ALEXANDER
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 02/03/2006
Decision Date 03/16/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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