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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name recorder, pressure, intrauterine
510(k) Number K791633
Device Name UC-2000 UTERINE CATHERIZATION SYSTEM
Applicant
LIFE SUPPORT, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LIFE SUPPORT, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.2700
Classification Product Code
HFO  
Date Received08/21/1979
Decision Date 09/17/1979
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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