510(k) K012684

REPROCESSED ELECTROSURGICAL ELECTRODE by Sterilmed, Inc. — Product Code JOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2002
Date Received
August 14, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type