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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K993950
Device Name CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999
Applicant
Nien Made Electrnics Corp.
100 Main St.
Suite 120
Concord,  MA  01742
Applicant Contact JAMES M DELANEY
Correspondent
Nien Made Electrnics Corp.
100 Main St.
Suite 120
Concord,  MA  01742
Correspondent Contact JAMES M DELANEY
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/22/1999
Decision Date 08/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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