FDA 510(k) Application Details - K043034

Device Classification Name Bone Grafting Material, Animal Source

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510(K) Number K043034
Device Name Bone Grafting Material, Animal Source
Applicant COLLAGEN MATRIX, INC.
509 COMMERCE ST.
FRANKLIN LAKES,, NJ 07417 US
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Contact PEGGY HANSEN
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Regulation Number 872.3930

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Classification Product Code NPM
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Date Received 11/03/2004
Decision Date 08/04/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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