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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, osteoinduction (w/o human growth factor)
510(k) Number K060180
Device Name BIOSET XC
Applicant
REGENERATION TECHNOLOGIES, INC.
11621 RESEARCH CIR.
P.O. BOX 2650
ALACHUA,  FL  32616 -2650
Applicant Contact Lisa Simpson
Correspondent
REGENERATION TECHNOLOGIES, INC.
11621 RESEARCH CIR.
P.O. BOX 2650
ALACHUA,  FL  32616 -2650
Correspondent Contact Lisa Simpson
Regulation Number888.3045
Classification Product Code
MBP  
Subsequent Product Code
MQV  
Date Received01/23/2006
Decision Date 09/06/2006
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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