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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 K031838
FOIA Releasable 510(k) K031838
Device Name PROFUSION BONE VOID FILLER KIT
Applicant
BIOGENERATION
9160 HIGHWAY 64
SUITE 12
LAKELAND,  TN  38002
Applicant Contact BERNARD F GRISONI
Correspondent
BIOGENERATION
9160 HIGHWAY 64
SUITE 12
LAKELAND,  TN  38002
Correspondent Contact BERNARD F GRISONI
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/16/2003
Decision Date 10/30/2003
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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