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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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More FDA Info for this Product Code
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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