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510(k) K200134

Jimushi Sterile Urethral Catheter for single use by Hangzhou Jimushi Meditech Co., Ltd. — Product Code GBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2020
Date Received
January 21, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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