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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 K092608
Device Name SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
Applicant
Collagen Matrix, Inc.
509 Commerce St.
Franklin Lakes,  NJ  07417
Applicant Contact PEGGY HANSEN
Correspondent
Collagen Matrix, Inc.
509 Commerce St.
Franklin Lakes,  NJ  07417
Correspondent Contact PEGGY HANSEN
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/25/2009
Decision Date 05/28/2010
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
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