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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 K151542
Device Name A-Oss
Applicant
Hiossen, Inc.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Applicant Contact David Kim
Correspondent
Hiossen, Inc.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Correspondent Contact David Kim
Regulation Number872.3930
Classification Product Code
NPM  
Date Received06/08/2015
Decision Date 08/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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