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510(k) K021166

ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR by Acmi-Circon Corporation — Product Code FDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2002
Date Received
April 11, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resectoscope, Working Element
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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