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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 K970884
Device Name RESOLUT REGENERATIVE MATERIAL
Applicant
W.L. Gore & Associates, Inc.
1500 N. Fourth St.
Flagstaff,  AZ  86004
Applicant Contact JACQUELINE KALBACH
Correspondent
W.L. Gore & Associates, Inc.
1500 N. Fourth St.
Flagstaff,  AZ  86004
Correspondent Contact JACQUELINE KALBACH
Regulation Number872.3930
Classification Product Code
LYC  
Date Received03/10/1997
Decision Date 05/08/1997
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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