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510(k) K905641

FST CATH-UD CATHETER by Fiberoptic Sensor Technlogies, Inc. — Product Code FEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1991
Date Received
December 18, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Cystometric, Hydraulic
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

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  • K930171 — FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR (November 4, 1993)
  • K922476 — URO-PRO 2000 (July 20, 1993)
  • K922776 — FST COUNCIL TIP FOLEY CATHETER (July 20, 1993)
  • K926088 — FST CATH UD-DUAL DUAL PRESSURE CATHETER (June 18, 1993)
  • K913113 — FST CATH-UD CATHETER, MODIFICATION (October 9, 1991)
  • K913721 — FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM (October 8, 1991)
  • K864000 — FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 (January 16, 1987)

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