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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K894033
Device Name DISPOSABLE CATHETER PRESSURE TRANSDUCER
Applicant
Deseret Medical, Inc.
9450 S. State St.
Sandy,  UT  84070
Applicant Contact CHARLES J WELLE
Correspondent
Deseret Medical, Inc.
9450 S. State St.
Sandy,  UT  84070
Correspondent Contact CHARLES J WELLE
Regulation Number870.2870
Classification Product Code
DXO  
Date Received06/06/1989
Decision Date 10/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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