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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 K063124
Device Name INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS
Applicant
INTEGRA LIFESCIENCES CORP.
311C ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Applicant Contact DIANA M BORDON
Correspondent
INTEGRA LIFESCIENCES CORP.
311C ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Correspondent Contact DIANA M BORDON
Regulation Number888.3045
Classification Product Code
MQV  
Date Received10/13/2006
Decision Date 01/19/2007
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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