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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Electrical Dental Anesthesia
510(k) Number K011001
Device Name TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM
Applicant
Satelec
70 Walnut St.
Wellesley,  MA  02481
Applicant Contact JEAN-LUC BOULNOIS
Correspondent
Satelec
70 Walnut St.
Wellesley,  MA  02481
Correspondent Contact JEAN-LUC BOULNOIS
Classification Product Code
LWM  
Date Received03/09/2001
Decision Date 06/07/2001
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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