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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 K935137
Device Name TEFGEN-FD
Applicant
American Custom Medical, Inc.
3403 73rd St.
Lubbock,  TX  79413
Applicant Contact BRUCE G RUEFER
Correspondent
American Custom Medical, Inc.
3403 73rd St.
Lubbock,  TX  79413
Correspondent Contact BRUCE G RUEFER
Regulation Number872.3930
Classification Product Code
NPK  
Date Received10/28/1993
Decision Date 08/15/1994
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
Recalls CDRH Recalls
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