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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Thermometer, Clinical Mercury
510(k) Number K903500
Device Name MASCOT THERMOTER
Applicant
Mascot, Inc.
16635 Valley View
Cerritos,  CA  90701
Correspondent
Mascot, Inc.
16635 Valley View
Cerritos,  CA  90701
Regulation Number880.2920
Classification Product Code
FLK  
Date Received08/03/1990
Decision Date 10/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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