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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 K973594
Device Name GORE RESOLUT XT REGENERATIVE MATERIAL
Applicant
W.L. GORE & ASSOCIATES,INC
301 AIRPORT RD
ELKTON,  MD  21922 -1408
Applicant Contact JOHN W NICHOLSON
Correspondent
W.L. GORE & ASSOCIATES,INC
301 AIRPORT RD
ELKTON,  MD  21922 -1408
Correspondent Contact JOHN W NICHOLSON
Regulation Number872.3930
Classification Product Code
LYC  
Date Received09/22/1997
Decision Date 12/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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