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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact GRAHAM BAILLIE
Regulation Number884.1700
Classification Product Code
HIG  
Date Received03/28/2011
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
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