510(k) K000905

URETHROTOME 8667.XXX AND 8670.XXX by Richard Wolf Medical Instruments Corp. — Product Code EZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2000
Date Received
March 21, 2000
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