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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 K040405
FOIA Releasable 510(k) K040405
Device Name CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY
Applicant
Berkeley Advanced Biomaterials, Inc.
1933 Davis St. Suite 307
San Leandro,  CA  94577
Applicant Contact FRANCOIS GENIN
Correspondent
Berkeley Advanced Biomaterials, Inc.
1933 Davis St. Suite 307
San Leandro,  CA  94577
Correspondent Contact FRANCOIS GENIN
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
GXP  
Date Received02/17/2004
Decision Date 03/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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