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510(k) K850694

WSP CODE 4310 STRESSCATH by Warne Surgical Products, Ltd. — Product Code FAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1985
Date Received
February 21, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

Other clearances by Warne Surgical Products, Ltd.

  • K850696 — WSP CODE 4300 DIOMASTER DIAGNOSTIC (May 17, 1985)
  • K850695 — WSP CODE 4301 DIOMASTER THERAPEUTIC (May 16, 1985)
  • K850693 — WSP CODE 4315 PADTEST (May 10, 1985)
  • K841511 — HAEMATURIA CATHETERS (July 12, 1984)
  • K840687 — KIDNEY TRANSPLANT CATHETER (June 7, 1984)
  • K841409 — BUSH NECK W/PLUG (April 18, 1984)
  • K841411 — ROLLED NECK W/PLUG (April 18, 1984)
  • K841412 — ROLLED NECK W/TAP (April 18, 1984)
  • K841410 — BUSH NECK W/TAP (April 18, 1984)
  • K840703 — SECURE W/30MM DIAM, SHEATH & ADHESIVE (March 22, 1984)

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  • K923995 — URODYNAMICS TUBING KITS #5161, #5150, #7170 (April 8, 1993)
  • K923464 — URODYNAMIC CATHETERS (February 5, 1993)