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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K983372
Device Name BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP
Applicant
SUNSCOPE INTL., INC.
148 SO. 1200 EAST
SALT LAKE CITY,  UT  84102
Applicant Contact PHIL TRIOLO
Correspondent
SUNSCOPE INTL., INC.
148 SO. 1200 EAST
SALT LAKE CITY,  UT  84102
Correspondent Contact PHIL TRIOLO
Regulation Number870.2850
Classification Product Code
DRS  
Date Received09/24/1998
Decision Date 02/05/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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