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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K000049
Device Name SUNI MAX
Applicant
Satelec
70 Walnut St.
Wellesley,  MA  02481
Applicant Contact JACQUELINE E MASSE
Correspondent
Satelec
70 Walnut St.
Wellesley,  MA  02481
Correspondent Contact JACQUELINE E MASSE
Regulation Number872.4200
Classification Product Code
EFB  
Date Received01/07/2000
Decision Date 04/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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