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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 K962624
Device Name RESOLUT REGENERATIVE MATERIAL
Applicant
W.L. GORE & ASSOCIATES,INC
1500 NORTH FOURTH ST.
FLAGSTAFF,  AZ  86004
Applicant Contact JACQUELINE KALBACH
Correspondent
W.L. GORE & ASSOCIATES,INC
1500 NORTH FOURTH ST.
FLAGSTAFF,  AZ  86004
Correspondent Contact JACQUELINE KALBACH
Regulation Number872.3930
Classification Product Code
LYC  
Date Received07/05/1996
Decision Date 10/03/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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