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510(k) K910195

BARD HYDROGEL-COATED FOLEY CATHETERS by C.R. Bard, Inc. — Product Code EZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1991
Date Received
January 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Coude
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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