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510(k) K970110

BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) by Bard Medical Div. — Product Code ODC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1997
Date Received
January 13, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Channel Accessory
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To give the endoscope channel additional or improved functionality.

Other clearances by Bard Medical Div.

  • K984136 — BARDEX LUBRI-SIL I.C. FOLEY CATHETER (February 16, 1999)
  • K984084 — BARDEX LUBRI-SIL FOLEY CATHETER (February 1, 1999)

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