DOLPHIN 3 FLUID MANAGEMENT SYSTEM


Device Classification Name

insufflator, hysteroscopic

510(k) Number K110852
Device Name DOLPHIN 3 FLUID MANAGEMENT SYSTEM
Applicant
GYRUS ACMI, INC.
136 turnpike rd.
southborough, 
MA 
01772

Applicant Contact graham baillie
Correspondent
GYRUS ACMI, INC.
136 turnpike rd.
southborough, 
MA 
01772

Correspodent Contact graham baillie
Regulation Number 884.1700
Classification Product Code
HIG  
Date Received 03/28/2011
Decision Date 07/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No