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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 K932866
Device Name RESOLUT REGENERATIVE MATERIAL
Applicant
W.L. Gore & Associates, Inc.
1500 N. Fourth St.
Flagstaff,  AZ  86001
Applicant Contact MARY EDWARDS
Correspondent
W.L. Gore & Associates, Inc.
1500 N. Fourth St.
Flagstaff,  AZ  86001
Correspondent Contact MARY EDWARDS
Regulation Number872.3930
Classification Product Code
LYC  
Date Received06/14/1993
Decision Date 03/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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