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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dura Substitute
510(k) Number K040888
Device Name DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
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 Number882.5910
Classification Product Code
GXQ  
Date Received04/05/2004
Decision Date 12/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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