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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameSYSTEM 37 HOME UTERINE ACTIVITY MONITORING SYSTEM
Classification Namehome uterine activity monitor
Generic Namehome uterine activity monitor system
Regulation Number884.2730
ApplicantMATRIA HEALTHCARE, INC.
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 Product No
Approval Order Statement 
Approval for system 37 home uterine activity monitor.
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