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510(k) K053322

MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS by Roei Medical Technologies, Ltd. — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2006
Date Received
November 30, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical, Active, Urological
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Roei Medical Technologies, Ltd.

  • K050910 — ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS (June 16, 2005)

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