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510(k) K190612

EQUINOX Balloon Dilatation Catheter by Dornier Medtech America, Inc. — Product Code EZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2019
Date Received
March 11, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Catheter, Ureteral
Device Class
Class II
Regulation Number
876.5470
Review Panel
GU
Submission Type

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