FDA 510(k) Application Details - K240661

Device Classification Name Bone Grafting Material, Animal Source

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510(K) Number K240661
Device Name Bone Grafting Material, Animal Source
Applicant Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen 6110 CH
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Contact Marco Steiner
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Regulation Number 872.3930

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Classification Product Code NPM
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Date Received 03/08/2024
Decision Date 07/12/2024
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

FDA Source Information for K240661


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