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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceCAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM
Generic NameHome uterine activity monitor
Regulation Number884.2730
ApplicantMATRIA HEALTHCARE, INC.
1850 PARKWAY PLACE
SUITE 1200
MARIETTA, GA 30067
PMA NumberP910063
Date Received10/21/1991
Decision Date09/29/1995
Reclassified Date 04/09/2001
Product Code LQK 
Docket Number 96M-0255
Notice Date 10/18/1996
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CAREFONE HOME UTERINE ACTIVITY MONITORING SYSTE, MODEL 2001
Supplements:  
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