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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 K072238
Device Name BIOSET XCH
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 Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
MPB  
Date Received08/13/2007
Decision Date 01/25/2008
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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