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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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