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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 K922627
Device Name GORE-TEX REGENERATIVE MATERIAL
Applicant
W.L. GORE & ASSOCIATES,INC
1500 NORTH FOURTH ST.
FLAGSTAFF,  AZ  86001
Applicant Contact MARY EDWARDS
Correspondent
W.L. GORE & ASSOCIATES,INC
1500 NORTH FOURTH ST.
FLAGSTAFF,  AZ  86001
Correspondent Contact MARY EDWARDS
Regulation Number872.3930
Classification Product Code
NPK  
Date Received06/03/1992
Decision Date 06/10/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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