510(k) K972749

PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) by C.M. Chance , Ltd. — Product Code HQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1998
Date Received
July 23, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Cautery, Radiofrequency, Ac-Powered
Device Class
Class II
Regulation Number
886.4100
Review Panel
OP
Submission Type