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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Esophageal, With Electrical Conductors
510(k) Number K862548
Device Name TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER
Applicant
Lawrence Medical Systems, Inc.
14910 NE 31st Circle
Redmond,  WA  98052
Applicant Contact RICHARD LEARY
Correspondent
Lawrence Medical Systems, Inc.
14910 NE 31st Circle
Redmond,  WA  98052
Correspondent Contact RICHARD LEARY
Regulation Number868.1920
Classification Product Code
BZT  
Date Received07/03/1986
Decision Date 10/22/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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