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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 K941283
Device Name INNERSENSE DISPOSABLE MICROTRANSDUCER
Applicant
Becton Dickinson Vascular Access, Inc.
9450 S. State St.
Sandy,  UT  84070
Applicant Contact CHARLES J WELLE
Correspondent
Becton Dickinson Vascular Access, Inc.
9450 S. State St.
Sandy,  UT  84070
Correspondent Contact CHARLES J WELLE
Regulation Number870.2870
Classification Product Code
DXO  
Date Received03/17/1994
Decision Date 04/19/1994
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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