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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 K002562
Device Name PACIFIER THERMOMETER MODELS VT-901F, VT901C
Applicant
Valeo Corp.
501 S. Andrews Ave.
Ft. Lauderdale,  FL  33301
Applicant Contact MARIAN HARDING COCHRAN
Correspondent
Valeo Corp.
501 S. Andrews Ave.
Ft. Lauderdale,  FL  33301
Correspondent Contact MARIAN HARDING COCHRAN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/17/2000
Decision Date 10/13/2000
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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