510(k) K972856

ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS by Rocket Medical Plc — Product Code KNF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1998
Date Received
August 1, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
Submission Type