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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Body Composition
510(k) Number K073334
Device Name OHMNISCAN NG
Applicant
Christine Valmy, Inc.
285, Change Bridge Rd.
Pine Brook,  NJ  07058
Applicant Contact PETER DEHAYDU
Correspondent
Christine Valmy, Inc.
285, Change Bridge Rd.
Pine Brook,  NJ  07058
Correspondent Contact PETER DEHAYDU
Regulation Number870.2770
Classification Product Code
MNW  
Date Received11/28/2007
Decision Date 08/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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