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FDA 510(k) Application Details - K052190
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K052190
Device Name
System, Monitoring, Perinatal
Applicant
BISTOS CO., LTD.
340 SHADY GROVE ROAD
FLINTVILLE, TN 37335 US
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Contact
CHARLIE MACK
Other 510(k) Applications for this Contact
Regulation Number
884.2740
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Classification Product Code
HGM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/11/2005
Decision Date
10/04/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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