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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 K103545
Device Name BT-350
Applicant
BISTOS CO., LTD.
4802 GLENWOOD ROAD
brooklyn,  NY  11234
Applicant Contact steve kohn
Correspondent
BISTOS CO., LTD.
4802 GLENWOOD ROAD
brooklyn,  NY  11234
Correspondent Contact steve kohn
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Code
HGL  
Date Received12/02/2010
Decision Date 05/13/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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