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510(k) K011149

DISPOSABLE BENDING CANNULA PR-233Q by The Olympus Optical Co. — Product Code ODD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2001
Date Received
April 16, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To identify stones, tumors, or narrowing in the biliary tree.

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  • K011869 — XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT (July 25, 2001)
  • K011151 — EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z (May 15, 2001)

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