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510(k) K121614

NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER by Boston Scientific Corp — Product Code LJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2012
Date Received
June 1, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nephrostomy
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

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