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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K961158
FOIA Releasable 510(k) K961158
Device Name SUPRASSON P5 BOOSTER
Applicant
Satelec
70 Walnut St.
Wellesley,  MA  02481
Applicant Contact JACKIE MASSE
Correspondent
Satelec
70 Walnut St.
Wellesley,  MA  02481
Correspondent Contact JACKIE MASSE
Regulation Number872.4850
Classification Product Code
ELC  
Date Received03/22/1996
Decision Date 05/23/1996
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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