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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 K031399
Device Name INTERGRO DBM
Applicant
INTERPORE CROSS INTL.
181 TECHNOLOGY DR.
IRVINE,  CA  92618 -2402
Applicant Contact MARK LOAR
Correspondent
INTERPORE CROSS INTL.
181 TECHNOLOGY DR.
IRVINE,  CA  92618 -2402
Correspondent Contact MARK LOAR
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
GXP  
Date Received05/05/2003
Decision Date 02/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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