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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Pressure, Gas
510(k) Number K850029
Device Name UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL
Applicant
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047 -1048
Applicant Contact DEAN WALLACE
Correspondent
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047 -1048
Correspondent Contact DEAN WALLACE
Regulation Number868.2620
Classification Product Code
BXX  
Date Received01/04/1985
Decision Date 04/29/1985
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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