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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 K910742
Device Name MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER
Applicant
GRAPHIC CONTROLS CORP.
189 VAN RENSSELAER ST.
P.O. BOX 1274
BUFFALO,  NY  14240
Applicant Contact VAN DINE
Correspondent
GRAPHIC CONTROLS CORP.
189 VAN RENSSELAER ST.
P.O. BOX 1274
BUFFALO,  NY  14240
Correspondent Contact VAN DINE
Regulation Number884.2700
Classification Product Code
KXO  
Date Received02/21/1991
Decision Date 01/14/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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