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510(k) K014002

ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 by Fortune Medical Instrument Corp. — Product Code KOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2002
Date Received
December 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Suprapubic (And Accessories)
Device Class
Class II
Regulation Number
876.5090
Review Panel
GU
Submission Type

Other clearances by Fortune Medical Instrument Corp.

  • K022112 — FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020 (April 3, 2003)
  • K021193 — FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 (February 12, 2003)
  • K021142 — ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 (October 1, 2002)
  • K980917 — ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RES (May 27, 1998)
  • K980919 — ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER (March 31, 1998)

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  • K012153 — LOWSLEY SUPRAPUBIC TRACTOR (September 19, 2001)
  • K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET (April 23, 1997)
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  • K945480 — MOSS(R) STEEL BREAKAWAY(R) INTRODUCER (August 28, 1995)