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510(k) K980919

ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER by Fortune Medical Instrument Corp. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1998
Date Received
March 11, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
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)
  • K014002 — ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 (March 4, 2002)
  • K980917 — ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RES (May 27, 1998)

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