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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 K890484
Device Name HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE
Applicant
Mallinckrodt Anesthesia Products
Hook Rd.
Argyle,  NY  12809
Applicant Contact E WIEGERT,PHD
Correspondent
Mallinckrodt Anesthesia Products
Hook Rd.
Argyle,  NY  12809
Correspondent Contact E WIEGERT,PHD
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/31/1989
Decision Date 04/21/1989
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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