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510(k) K000251

SPECTRUM SILICONE FOLEY CATHETER by Cook Urological, Inc. — Product Code MJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2000
Date Received
January 27, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological (Antimicrobial) And Accessories
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Cook Urological, Inc.

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  • K082939 — COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 (September 3, 2009)
  • K082066 — TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER (November 7, 2008)
  • K082536 — COOK WIRE GUIDES (October 27, 2008)
  • K082319 — INJEKT FILIFORM INJECTION NEEDLE (September 25, 2008)
  • K080525 — COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W (April 17, 2008)
  • K073496 — OPTILITE HOLMIUM LASER FIBERS (January 23, 2008)
  • K072521 — COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (November 20, 2007)
  • K061371 — SYDNEY IVF SPERM CRYOPRESERVATION BUFFER (August 17, 2006)

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  • K993464 — BARDEX I.C. PEDIATRIC FOLEY CATHETER (December 10, 1999)
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  • K983101 — BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 (November 3, 1998)
  • K971627 — SILICONE ANTIBACTERIAL FOLEY CATHETER (January 13, 1998)
  • K910318 — BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER (August 18, 1994)