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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 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
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
Predetermined Change
Control Plan Authorized		 No
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