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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 K211551
Device Name Wishbone HA
Applicant
Wishbone SA
1, Rue de 1'Expansion
Flemalle,  BE 4400
Applicant Contact Emilie Dory
Correspondent
Wishbone SA
1, Rue de 1'Expansion
Flemalle,  BE 4400
Correspondent Contact Emilie Dory
Regulation Number872.3930
Classification Product Code
NPM  
Date Received05/19/2021
Decision Date 08/20/2021
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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