510(k) K963852

KSEA THERMOCOAGULATOR (MODEL 265100 20) by KARL STORZ Endoscopy-America, Inc. — Product Code HGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1996
Date Received
September 25, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocautery, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.4120
Review Panel
OB
Submission Type