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510(k) K031001

ACMI VISTA CTR BIPOLAR LOOP ELECTRODE by Acmi Corporation — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2003
Date Received
March 31, 2003
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

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