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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(k) Number K905148
Device Name TEMPERATURE PROBE
Applicant
Tec II Medical, Inc.
917 W. Jefferson
Blue Springs,  MO  64015
Applicant Contact JOSEPH BROWN
Correspondent
Tec II Medical, Inc.
917 W. Jefferson
Blue Springs,  MO  64015
Correspondent Contact JOSEPH BROWN
Regulation Number868.5240
Classification Product Code
CAI  
Date Received11/15/1990
Decision Date 04/01/1991
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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