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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 K040562
Device Name LIFECLINIC, MODEL 2400
Applicant
Lifeclinic International, Inc.
377 Route 17s
Hasbrouck Heights,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
Lifeclinic International, Inc.
377 Route 17s
Hasbrouck Heights,  NJ  07604
Correspondent Contact GEORGE MYERS
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/03/2004
Decision Date 08/31/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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