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510(k) K222118

2-Way 100% Silicone Cleartract Catheter by Silq Technologies, Corp. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2022
Date Received
July 18, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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