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510(k) K973820

USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE by Circon Corp. — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1998
Date Received
October 7, 1997
Clearance Type
Traditional
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

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  • K980972 — RIGID CULDOSCOPE AND ACCESSORIES (June 12, 1998)
  • K964594 — VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VA (August 15, 1997)

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