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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, Synthetic
510(k) Number K131385
Device Name EASY-GRAFT
Applicant
Degradable Solutions AG
901 King St., Suite 101
Alexandria,  VA  22314
Applicant Contact DEBORAH LAVOIE GRAYESKI
Correspondent
Degradable Solutions AG
901 King St., Suite 101
Alexandria,  VA  22314
Correspondent Contact DEBORAH LAVOIE GRAYESKI
Regulation Number872.3930
Classification Product Code
LYC  
Date Received05/14/2013
Decision Date 09/27/2013
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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