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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 K964279
Device Name SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
Applicant
GRAPHIC CONTROLS CORP.
189 VAN RENSSELAER ST.
P.O. BOX 1271
BUAFFLO,  NY  14240 -1271
Applicant Contact KATHLEEN H SELOVER
Correspondent
GRAPHIC CONTROLS CORP.
189 VAN RENSSELAER ST.
P.O. BOX 1271
BUAFFLO,  NY  14240 -1271
Correspondent Contact KATHLEEN H SELOVER
Regulation Number884.2700
Classification Product Code
KXO  
Date Received10/28/1996
Decision Date 01/22/1997
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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