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510(k) K904939

FLEXIBLE AND RIGID URETEROTOME SYSTEM by Olympus Corp. — Product Code EZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1992
Date Received
November 1, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urethrotome
Device Class
Class II
Regulation Number
876.4770
Review Panel
GU
Submission Type

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Other clearances for product code EZO

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  • K934730 — KARL STORZ ENDOSCOPIC COLD KNIFE BLADES (January 11, 1994)