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510(k) K993464

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1999
Date Received
October 13, 1999
Clearance Type
Abbreviated
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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Other clearances for product code MJC

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  • K983101 — BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 (November 3, 1998)
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