Home / 510(k) Clearances / K213575

510(k) K213575

Female IC (Not Finalized) by Hollister Incorporated — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2022
Date Received
November 10, 2021
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

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