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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 K874514
Device Name HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE
Applicant
Mallinckrodt Critical Care
Hook Rd.
Argyle,  NY  12809
Applicant Contact PHILIP E WIEGERT
Correspondent
Mallinckrodt Critical Care
Hook Rd.
Argyle,  NY  12809
Correspondent Contact PHILIP E WIEGERT
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/02/1987
Decision Date 01/29/1988
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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