OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2

Pump, Air, Non-manual, For Endoscope

KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.

The following data is part of a premarket notification filed by Keymed (medical & Industrial Equipment), Ltd. with the FDA for Olympus Endoscopic Flushing Pump, Model Opf-2.

Pre-market Notification Details

Device IDK100899
510k NumberK100899
Device Name:OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2
ClassificationPump, Air, Non-manual, For Endoscope
Applicant KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. 11440 WEST BERNARDO DRIVE SUITE 300 San Diego,  CA  92127
ContactRon Warren
CorrespondentRon Warren
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. 11440 WEST BERNARDO DRIVE SUITE 300 San Diego,  CA  92127
Product CodeFEQ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-31
Decision Date2010-09-13
Summary:summary

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