FDA 510(k) Application Details - K211551

Device Classification Name Bone Grafting Material, Animal Source

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510(K) Number K211551
Device Name Bone Grafting Material, Animal Source
Applicant Wishbone SA
1, Rue de 1'Expansion
Flemalle 4400 BE
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Contact Emilie Dory
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Regulation Number 872.3930

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Classification Product Code NPM
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Date Received 05/19/2021
Decision Date 08/20/2021
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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