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510(k) K192691

PatCom Single-Use Introducer by H&A Mui Enterprises, Inc. — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2020
Date Received
September 26, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

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