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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 K082498
Device Name GRAFTYS HBS
Applicant
GRAFTYS
415 RUE CHARLES NICOLAS LEDOUX
EIFFEL PARK BAT D
AIX EN PROVENCE,  FR 13854
Applicant Contact ANTHONY LE NAOUR
Correspondent
GRAFTYS
415 RUE CHARLES NICOLAS LEDOUX
EIFFEL PARK BAT D
AIX EN PROVENCE,  FR 13854
Correspondent Contact ANTHONY LE NAOUR
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/29/2008
Decision Date 02/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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