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510(k) K950719

OES UROLOGY by Olympus America, Inc. — Product Code EZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1996
Date Received
February 16, 1995
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)
  • K904939 — FLEXIBLE AND RIGID URETEROTOME SYSTEM (January 7, 1992)