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510(k) K984084

BARDEX LUBRI-SIL FOLEY CATHETER by Bard Medical Div. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1999
Date Received
November 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Bard Medical Div.

  • K984136 — BARDEX LUBRI-SIL I.C. FOLEY CATHETER (February 16, 1999)
  • K970110 — BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) (February 19, 1997)

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