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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Animal Source, Intraoral
510(k) Number K230091
Device Name THE Cover
Applicant
Purgo Biologics, Inc.
#812, 27 Dunchon-Daero 457 Beon-Gil, Jungwon-Gu
Seongnam-Si,  KR 13219
Applicant Contact Byungsun Kim
Correspondent
Purgo Biologics, Inc.
#812, 27 Dunchon-Daero 457 Beon-Gil, Jungwon-Gu
Seongnam-Si,  KR 13219
Correspondent Contact Byungsun Kim
Regulation Number872.3930
Classification Product Code
NPL  
Date Received01/12/2023
Decision Date 10/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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