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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Human Source
510(k) Number K080418
Device Name REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST
Applicant
Regeneration Technologies, Inc.
11621 Research Cir.
P.O. Box 2650
Alachua,  FL  32616 -2650
Applicant Contact TRAVIS AROLA
Correspondent
Regeneration Technologies, Inc.
11621 Research Cir.
P.O. Box 2650
Alachua,  FL  32616 -2650
Correspondent Contact TRAVIS AROLA
Regulation Number872.3930
Classification Product Code
NUN  
Date Received02/15/2008
Decision Date 04/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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