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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 K874165
Device Name DISPOSABLE CATHETER PRESSURE TRANSDUCER
Applicant
Deseret Medical, Inc.
9450 S. State St.
Sandy,  UT  84070
Applicant Contact CLEARY
Correspondent
Deseret Medical, Inc.
9450 S. State St.
Sandy,  UT  84070
Correspondent Contact CLEARY
Regulation Number870.2870
Classification Product Code
DXO  
Date Received10/13/1987
Decision Date 06/09/1988
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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