510(k) K093079

TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U by Hobbs Medical, Inc. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2010
Date Received
September 30, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type