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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bone grafting material, animal source
510(k) Number K231672
Device Name S1
Applicant
MedPark Co., Ltd.
24, Nakdong-daero 1570 beon-gil,
Buk-gu,  KR
Applicant Contact Woojong Kim
Correspondent
MedPark Co., Ltd.
Busan Venture Tower 606-ho, 22, Mora-ro
Sasang-gu,  KR
Correspondent Contact Woojong Kim
Regulation Number872.3930
Classification Product Code
NPM  
Date Received06/08/2023
Decision Date 10/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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