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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 K011876
Device Name DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
Applicant
CIRCON VIDEO
492 OLD CONNECTICUT PATH
FRAMINGHAM,  MA  01701 -4584
Applicant Contact John DeLucia
Correspondent
CIRCON VIDEO
492 OLD CONNECTICUT PATH
FRAMINGHAM,  MA  01701 -4584
Correspondent Contact John DeLucia
Regulation Number884.1700
Classification Product Code
HIG  
Date Received06/15/2001
Decision Date 01/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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