FDA 510(k) Application Details - K231672

Device Classification Name Bone Grafting Material, Animal Source

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510(K) Number K231672
Device Name Bone Grafting Material, Animal Source
Applicant MedPark Co., Ltd.
24, Nakdong-daero 1570 beon-gil,
Buk-gu KR
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Contact Woojong Kim
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Regulation Number 872.3930

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Classification Product Code NPM
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Date Received 06/08/2023
Decision Date 10/13/2023
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 K231672


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