FDA 510(k) Application Details - K140021

Device Classification Name Bone Grafting Material, Animal Source

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510(K) Number K140021
Device Name Bone Grafting Material, Animal Source
Applicant CHIYEWON
4568 W. 1ST ST. STE 104
LOS ANGELES, CA 90004 US
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Contact DANIEL NAM
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Regulation Number 872.3930

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Classification Product Code NPM
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Date Received 01/03/2014
Decision Date 06/05/2015
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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