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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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More FDA Info for this Product Code
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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