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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K954775
Device Name FLO-STAT FLUID MONITORING SYSTEM
Applicant
GYNECARE INNOVATION CENTER
1221 INNSBRUCK DR.
SUNNYVALE,  CA  94089
Applicant Contact MICHAEL A DANIEL
Correspondent
GYNECARE INNOVATION CENTER
1221 INNSBRUCK DR.
SUNNYVALE,  CA  94089
Correspondent Contact MICHAEL A DANIEL
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Code
HIH  
Date Received10/17/1995
Decision Date 05/10/1996
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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