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FDA 510(k) Application Details - K991235
Device Classification Name
Monitor, Pressure, Intrauterine
More FDA Info for this Device
510(K) Number
K991235
Device Name
Monitor, Pressure, Intrauterine
Applicant
LUDLOW TECHNICAL PRODUCTS
TWO LUDLOW PARK
CHICOPEE, MA 01022 US
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Contact
KATHLEEN M MURPHY
Other 510(k) Applications for this Contact
Regulation Number
884.2700
More FDA Info for this Regulation Number
Classification Product Code
KXO
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More FDA Info for this Product Code
Date Received
04/12/1999
Decision Date
07/08/1999
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
N
Expedited Review
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