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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 K854299
Device Name GORE-TEX PERIODONTAL MATERIAL
Applicant
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
P.O. Box 500
Flagstaff,  AZ  86002
Applicant Contact MARY EDWARDS
Correspondent
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
P.O. Box 500
Flagstaff,  AZ  86002
Correspondent Contact MARY EDWARDS
Regulation Number872.3930
Classification Product Code
NPK  
Date Received10/25/1985
Decision Date 05/19/1986
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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