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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
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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