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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 K132325
Device Name GUIDOR BIORESORBABLE MATRIX BARRIER
Applicant
Sunstar Americas, Inc.
575 8th Ave.
Suite 1212
New York,  NY  10018
Applicant Contact DEBORAH L GRAYESKI
Correspondent
Sunstar Americas, Inc.
575 8th Ave.
Suite 1212
New York,  NY  10018
Correspondent Contact DEBORAH L GRAYESKI
Regulation Number872.3930
Classification Product Code
NPK  
Date Received07/26/2013
Decision Date 10/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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