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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K053209
Device Name TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM
Applicant
Suntech Medical, Inc.
377 Rte. 17
Hasbrouck Heights,  NJ  07460
Applicant Contact GEORGE MYERS
Correspondent
Suntech Medical, Inc.
377 Rte. 17
Hasbrouck Heights,  NJ  07460
Correspondent Contact GEORGE MYERS
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/16/2005
Decision Date 01/05/2006
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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