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510(k) K965118

ENDOCARE MONOPOLAR ELECTRODE by Endocare, Inc. — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1997
Date Received
December 20, 1996
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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  • K011074 — CRYOCARE SURGICAL SYSTEM (January 25, 2002)
  • K003811 — CRYOCARE SURGICAL SYSTEM (October 11, 2001)

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