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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 K844201
Device Name HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR
Applicant
Mallinckrodt Critical Care
73 Quaker Rd.
Glens Falls,  NY  12301
Applicant Contact PHILIP E WIEGERT
Correspondent
Mallinckrodt Critical Care
73 Quaker Rd.
Glens Falls,  NY  12301
Correspondent Contact PHILIP E WIEGERT
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/30/1984
Decision Date 03/04/1985
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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