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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 K073341
Device Name GENEX PUTTY
Applicant
BIOCOMPOSITES LTD.
KEELE SCIENCE PARK
KEELE, STAFFORDSHIRE,  GB ST5 5NL
Applicant Contact SIMON FITZER
Correspondent
BIOCOMPOSITES LTD.
KEELE SCIENCE PARK
KEELE, STAFFORDSHIRE,  GB ST5 5NL
Correspondent Contact SIMON FITZER
Regulation Number888.3045
Classification Product Code
MQV  
Date Received11/28/2007
Decision Date 07/09/2008
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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