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510(k) K973504

UROSURGE UROSTENT by Princeton Regulatory Assoc. — Product Code FAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1998
Date Received
September 16, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type

Other clearances by Princeton Regulatory Assoc.

  • K965136 — UROSURGE UROTHERM FLUID WARMING SYSTEM (October 16, 1998)
  • K972158 — GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES (February 20, 1998)
  • K962770 — UROSURGE ACUTRAINER (August 1, 1996)

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