FLO-STAT FLUID MONITORING SYSTEM

Laparoscope, Gynecologic (and Accessories)

GYNECARE INNOVATION CENTER

The following data is part of a premarket notification filed by Gynecare Innovation Center with the FDA for Flo-stat Fluid Monitoring System.

Pre-market Notification Details

Device IDK954775
510k NumberK954775
Device Name:FLO-STAT FLUID MONITORING SYSTEM
ClassificationLaparoscope, Gynecologic (and Accessories)
Applicant GYNECARE INNOVATION CENTER 1221 INNSBRUCK DR. Sunnyvale,  CA  94089
ContactMichael A Daniel
CorrespondentMichael A Daniel
GYNECARE INNOVATION CENTER 1221 INNSBRUCK DR. Sunnyvale,  CA  94089
Product CodeHET  
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-17
Decision Date1996-05-10

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