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FDA 510(k) Application Details - K173188
Device Classification Name
Bone Grafting Material, Animal Source
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510(K) Number
K173188
Device Name
Bone Grafting Material, Animal Source
Applicant
Purgo Biologics Inc.
E-607, 700, Pangyo-ro
Bundang-gu
Seongnam-si 13516 KR
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Contact
Hana Jung
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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
10/02/2017
Decision Date
07/20/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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