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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 K020537
Device Name TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM
Applicant
Tensys Medical, Inc.
5825 Oberlin Dr., Suite 100
San Diego,  CA  92121
Applicant Contact STUART L GALLANT
Correspondent
Quality Systems Resources (Qsr)
4141 Elm Rd.
Hudson,  MI  49247
Correspondent Contact Kenneth K. Kleinhenz
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/19/2002
Decision Date 08/15/2002
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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