DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2

Insufflator, Hysteroscopic

CIRCON VIDEO

The following data is part of a premarket notification filed by Circon Video with the FDA for Dolphin Ii Fluid Management System, Model Dol-2.

Pre-market Notification Details

Device IDK011876
510k NumberK011876
Device Name:DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
ClassificationInsufflator, Hysteroscopic
Applicant CIRCON VIDEO 492 OLD CONNECTICUT PATH Framingham,  MA  01701 -4584
ContactJohn Delucia
CorrespondentJohn Delucia
CIRCON VIDEO 492 OLD CONNECTICUT PATH Framingham,  MA  01701 -4584
Product CodeHIG  
CFR Regulation Number884.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-15
Decision Date2002-01-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821925001770 K011876 000

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