PANCREATIC DRAINAGE TUBE

Stents, Drains And Dilators For The Biliary Ducts

AOMORI OLYMPUS CO., LTD.

The following data is part of a premarket notification filed by Aomori Olympus Co., Ltd. with the FDA for Pancreatic Drainage Tube.

Pre-market Notification Details

Device IDK021672
510k NumberK021672
Device Name:PANCREATIC DRAINAGE TUBE
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant AOMORI OLYMPUS CO., LTD. 2 CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactLaura Storms-tyler
CorrespondentLaura Storms-tyler
AOMORI OLYMPUS CO., LTD. 2 CORPORATE CENTER DR. Melville,  NY  11747 -3157
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-21
Decision Date2003-04-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170152303 K021672 000
14953170152020 K021672 000
14953170152006 K021672 000
14953170461214 K021672 000
14953170461191 K021672 000
14953170461092 K021672 000
14953170461078 K021672 000
14953170461054 K021672 000
14953170461030 K021672 000
14953170461016 K021672 000
14953170460996 K021672 000
14953170460972 K021672 000
14953170152044 K021672 000
14953170152068 K021672 000
14953170152280 K021672 000
14953170152266 K021672 000
14953170152242 K021672 000
14953170152228 K021672 000
14953170152204 K021672 000
14953170152181 K021672 000
14953170152167 K021672 000
14953170152143 K021672 000
14953170152129 K021672 000
14953170152105 K021672 000
14953170152082 K021672 000
14953170460958 K021672 000

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