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510(k) K181616

PSM 3-Way Silicone Foley Catheter by Pathway, LLC — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2018
Date Received
June 19, 2018
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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