DOLPHIN 3 FLUID MANAGEMENT SYSTEM

Insufflator, Hysteroscopic

GYRUS ACMI, INC.

The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Dolphin 3 Fluid Management System.

Pre-market Notification Details

Device IDK110852
510k NumberK110852
Device Name:DOLPHIN 3 FLUID MANAGEMENT SYSTEM
ClassificationInsufflator, Hysteroscopic
Applicant GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough,  MA  01772
ContactGraham Baillie
CorrespondentGraham Baillie
GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough,  MA  01772
Product CodeHIG  
CFR Regulation Number884.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-28
Decision Date2011-07-19
Summary:summary

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