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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 K040410
Device Name GREENLIGHT 300
Applicant
A C Cossor & Son (Surgical) Limited
Vale Rd.
London,  GB N4 1PS
Applicant Contact A J COSSOR
Correspondent
A C Cossor & Son (Surgical) Limited
Vale Rd.
London,  GB N4 1PS
Correspondent Contact A J COSSOR
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/18/2004
Decision Date 05/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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