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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 K051267
Device Name GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE
Applicant
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.,
P.O.Box 500
Flagstaff,  AZ 
Applicant Contact JACQUELINE KALBACH
Correspondent
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.,
P.O.Box 500
Flagstaff,  AZ 
Correspondent Contact JACQUELINE KALBACH
Regulation Number872.3930
Classification Product Code
NPK  
Date Received05/16/2005
Decision Date 06/15/2005
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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