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510(k) K211436

Intermittent Catheter (Not Finalized) by Hollister Incorporated — Product Code GBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2022
Date Received
May 10, 2021
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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