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510(k) K040658

BARDEX I.C. LATEX FOLEY CATHETER by C.R. Bard, Inc. — Product Code MJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2004
Date Received
March 12, 2004
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

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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)
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