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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 K913042
Device Name MODIFICATIONS TO SERIES OF CARDIAC CATHETERS
Applicant
Sentron, Inc.
34008 9th Ave. S.
Federal Way,  WA  98003
Applicant Contact JOHN BREKKE
Correspondent
Sentron, Inc.
34008 9th Ave. S.
Federal Way,  WA  98003
Correspondent Contact JOHN BREKKE
Regulation Number870.2870
Classification Product Code
DXO  
Date Received06/25/1991
Decision Date 10/21/1992
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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