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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceSYSTEM 37 HOME UTERINE ACTIVITY MONITORING SYSTEM
Generic NameHome uterine activity monitor
Regulation Number884.2730
ApplicantMATRIA HEALTHCARE, INC.
1850 PARKWAY PLACE
SUITE 1200
MARIETTA, GA 30067
PMA NumberP920038
Date Received07/24/1992
Decision Date09/29/1995
Reclassified Date 04/09/2001
Product Code LQK 
Docket Number 96m-0220
Notice Date 07/18/1996
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR SYSTEM 37 HOME UTERINE ACTIVITY MONITOR
Supplements:  
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