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FDA 510(k) Application Details - K131385
Device Classification Name
Bone Grafting Material, Synthetic
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510(K) Number
K131385
Device Name
Bone Grafting Material, Synthetic
Applicant
Degradable Solutions AG
901 KING STREET
SUITE 101
ALEXANDRIA, VA 22314 US
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Contact
DEBORAH LAVOIE GRAYESKI
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Regulation Number
872.3930
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Classification Product Code
LYC
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More FDA Info for this Product Code
Date Received
05/14/2013
Decision Date
09/27/2013
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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