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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 K896122
Device Name AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED
Applicant
SPECTRAMED, INC.
1900 williams dr.
oxnard,  CA  93030
Applicant Contact robert l leavitt
Correspondent
SPECTRAMED, INC.
1900 williams dr.
oxnard,  CA  93030
Correspodent Contact robert l leavitt
Regulation Number884.2700
Classification Product Code
KXO  
Date Received10/24/1989
Decision Date 01/19/1990
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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