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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 K072698
Device Name CONFIDANT 2.5
Applicant
CONFIDANT INC.
2530 MERIDIAN PARKWAY
SUITE 300
DURHAM,  NC  27713
Applicant Contact DANIEL R PLONSKI
Correspondent
CONFIDANT INC.
2530 MERIDIAN PARKWAY
SUITE 300
DURHAM,  NC  27713
Correspondent Contact DANIEL R PLONSKI
Regulation Number870.2910
Classification Product Code
DRG  
Date Received09/24/2007
Decision Date 11/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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