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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Synthetic, Intraoral
510(k) Number K160493
Device Name Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm
Applicant
Salvin Dental Specialties
3450 Latrobe Dr.
Charlotte,  NC  28211
Applicant Contact Jennifer Singer
Correspondent
Kapstone Medical
100 E. S. Main St., P.O. Box 1458
Waxhaw,  NC  28173
Correspondent Contact John Kapitan
Regulation Number872.3930
Classification Product Code
NPK  
Date Received02/22/2016
Decision Date 09/08/2016
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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