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510(k) K181445

AMSure Hydrophilic Intermittent Catheter by Amsino International, Inc. — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2018
Date Received
June 1, 2018
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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