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510(k) K181814

AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water by Amsino International, Inc. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2018
Date Received
July 9, 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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