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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 K051615
Device Name STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES
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 Received06/17/2005
Decision Date 08/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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