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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Pressure, Intrauterine
510(k) Number K991235
Device Name SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)
Applicant
LUDLOW TECHNICAL PRODUCTS
TWO LUDLOW PARK
CHICOPEE,  MA  01022
Applicant Contact KATHLEEN M MURPHY
Correspondent
LUDLOW TECHNICAL PRODUCTS
TWO LUDLOW PARK
CHICOPEE,  MA  01022
Correspondent Contact KATHLEEN M MURPHY
Regulation Number884.2700
Classification Product Code
KXO  
Date Received04/12/1999
Decision Date 07/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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