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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K962918
Device Name LIDCO SYSTEM
Applicant
Lidco, Ltd.
16809 Briardale Rd.
Rockville,  MD  20850
Applicant Contact TOM TSAKERIS
Correspondent
Lidco, Ltd.
16809 Briardale Rd.
Rockville,  MD  20850
Correspondent Contact TOM TSAKERIS
Regulation Number870.1435
Classification Product Code
DXG  
Date Received06/27/1996
Decision Date 01/08/1999
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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