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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 K043421
Device Name OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC
Applicant
REGENERATION TECHNOLOGIES, INC.
11621 RESEARCH CIR.
P.O. BOX 2650
ALACHUA,  FL  32616 -2650
Applicant Contact CARRIE HARTILL
Correspondent
REGENERATION TECHNOLOGIES, INC.
11621 RESEARCH CIR.
P.O. BOX 2650
ALACHUA,  FL  32616 -2650
Correspondent Contact CARRIE HARTILL
Regulation Number888.3045
Classification Product Code
MQV  
Date Received12/13/2004
Decision Date 02/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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