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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transmitters and receivers, physiological signal, radiofrequency
510(k) Number K092635
Device Name ALCATEL-LUCENT TELEHEATH MANAGER
Applicant
ALCATEL-LUCENT CANADA INC.
1380 RODICK RD.
MARKHAM, ON,  CA L3R 4G5
Applicant Contact ALEX GIOSA
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DXN   NBW  
Date Received08/27/2009
Decision Date 09/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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