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FDA 510(k) Application Details - K202183
Device Classification Name
Bone Grafting Material, Animal Source
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510(K) Number
K202183
Device Name
Bone Grafting Material, Animal Source
Applicant
Collagen Matrix, Inc.
15 Thornton Road
Oakland, NJ 07436 US
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Contact
Gloria Zuclich
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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
08/04/2020
Decision Date
04/02/2021
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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