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510(k) K910318

BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER by C.R. Bard, Inc. — Product Code MJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1994
Date Received
January 24, 1991
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)
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