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510(k) K220667

Sleeved IC by Hollister Incorporated — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2022
Date Received
March 7, 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

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Other clearances for product code EZD

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  • K250659 — LoFric Origo (September 26, 2025)
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  • K251116 — Luja Coudé (June 27, 2025)
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  • K250270 — Luja Set (April 17, 2025)
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