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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 K213904
Device Name Kerecis Oral
Applicant
Kerecis
Eyrargata 2
Isafjordur,  IS 400
Applicant Contact Gudmundur Fertram Sigurjonsson
Correspondent
Kerecis
Eyrargata 2
Isafjordur,  IS 400
Correspondent Contact Gudmundur Fertram Sigurjonsson
Regulation Number872.3930
Classification Product Code
NPL  
Date Received12/14/2021
Decision Date 09/30/2022
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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