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510(k) K222677

Intermittent nelaton catheter for single use by Hangzhou Jimushi Meditech Co., Ltd. — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2023
Date Received
September 6, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Straight
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Hangzhou Jimushi Meditech Co., Ltd.

  • K200134 — Jimushi Sterile Urethral Catheter for single use (June 1, 2020)

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