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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 K240133
Device Name Xenograft Bovine Bone Particulate
Applicant
Collagen Solutions, LLC
6455 City W. Pkwy.
Eden Prairie,  MN  55344
Applicant Contact Sheila Hunter
Correspondent
MEDIcept, Inc.
200 Homer Ave.,
Ashland,  MA  01721
Correspondent Contact Richelle Helman
Regulation Number872.3930
Classification Product Code
NPM  
Date Received01/18/2024
Decision Date 08/16/2024
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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