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510(k) K212151

FLUME catheter by The Flume Catheter Company, Ltd. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2021
Date Received
July 9, 2021
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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