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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 K943362
Device Name PACIFIER-THERMOMETER
Applicant
Questech Intl., Inc.
4951-B E. Adamo Dr.,
Suite 238
Tampa,  FL  33605
Applicant Contact PATRICK LAMB
Correspondent
Questech Intl., Inc.
4951-B E. Adamo Dr.,
Suite 238
Tampa,  FL  33605
Correspondent Contact PATRICK LAMB
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/13/1994
Decision Date 02/21/1995
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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