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510(k) K843214

EPHAR by Akron City Hospital — Product Code FFI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 29, 1984
Date Received: August 15, 1984
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Alarm, Electrosurgical
Device Class: Class II
Regulation Number: 876.4300
Review Panel: GU
Submission Type