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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K981171
Device Name ERADIC-ALL
Applicant
Theratechnologies, Inc.
630,Boul. Rene-Levesque Quest
5e Etage
Montreal Quebec,  CA H3B 1S6
Applicant Contact ANDRE DE VILLERS
Correspondent
Theratechnologies, Inc.
630,Boul. Rene-Levesque Quest
5e Etage
Montreal Quebec,  CA H3B 1S6
Correspondent Contact ANDRE DE VILLERS
Regulation Number872.6640
Classification Product Code
EIA  
Date Received04/01/1998
Decision Date 12/02/1998
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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