DISPOSABLE BENDING CANNULA PR-233Q

Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula

THE OLYMPUS OPTICAL CO.

The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Disposable Bending Cannula Pr-233q.

Pre-market Notification Details

Device IDK011149
510k NumberK011149
Device Name:DISPOSABLE BENDING CANNULA PR-233Q
ClassificationEndoscopic Retrograde Cholangiopancreatography (ercp) Cannula
Applicant THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE Melville,  NY  11747 -3157
ContactLaura Stoms-tyler
CorrespondentLaura Stoms-tyler
THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE Melville,  NY  11747 -3157
Product CodeODD  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-16
Decision Date2001-05-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170044240 K011149 000

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