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510(k) K903994

URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION by Applied Urology, Inc. — Product Code FGF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1990
Date Received
August 29, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ureteral Disposable (X-Ray)
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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  • K901214 — RIGID URETEROSCOPE (June 1, 1990)