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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K052715
Device Name CALM CURVE, VERSION 01.00
Applicant
LMS MEDICAL SYSTEMS (CANADA), LTD.
5252 DE MAISONNEUVE WEST, #314
MONTREAL, QC,  CA H4A 3S5
Applicant Contact PAMELA HASWELL
Correspondent
LMS MEDICAL SYSTEMS (CANADA), LTD.
5252 DE MAISONNEUVE WEST, #314
MONTREAL, QC,  CA H4A 3S5
Correspondent Contact PAMELA HASWELL
Regulation Number884.2740
Classification Product Code
HGM  
Date Received09/29/2005
Decision Date 12/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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