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510(k) K933941

MENLO CARE URINARY DIVERSION STENT by Menlo Care, Inc. — Product Code FAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1994
Date Received
August 12, 1993
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 Menlo Care, Inc.

  • K964447 — PICC CATHETER/MIDLINE CATHETER (April 16, 1997)
  • K951620 — MIDMARK MIDLINE CATHETER (April 4, 1996)
  • K945521 — CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY (April 6, 1995)
  • K944968 — LANDMARK MIDLINE CATHETER (March 29, 1995)
  • K950737 — LANDMARK MIDLINE CATHETER (March 29, 1995)
  • K943893 — PERCUTANEOUS GRAINAGE CATHETER (March 7, 1995)
  • K943143 — BILIARY STENT (February 28, 1995)
  • K930048 — SAFE-PICC CATHETER (May 12, 1994)
  • K940127 — CENTERMARK SECURING WINGS (February 9, 1994)
  • K923394 — MENLO CARE AQUASTENT SET (November 16, 1993)

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