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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 K965205
Device Name TEFGEN - LS
Applicant
American Custom Medical, Inc.
2430 N. 7th Ave., #4
Bozeman,  MT  59715
Applicant Contact BRUCE G RUEFER
Correspondent
American Custom Medical, Inc.
2430 N. 7th Ave., #4
Bozeman,  MT  59715
Correspondent Contact BRUCE G RUEFER
Regulation Number872.3930
Classification Product Code
NPK  
Date Received12/26/1996
Decision Date 04/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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