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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
Recalls CDRH Recalls
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