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510(k) K153655

Accuryn Monitoring System by Potrero Medical, Inc. — Product Code EZL

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 15, 2016
Date Received
December 21, 2015
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

Other clearances by Potrero Medical, Inc.

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