FDA 510(k) Application Details - K121881

Device Classification Name	Electrocautery, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K121881
Device Name	Electrocautery, Gynecologic (And Accessories)
Applicant	DOMAIN SURGICAL, INC. 1370 SOUTH 2100 EAST SALT LAKE SITY, UT 84108 US Other 510(k) Applications for this Company
Contact	CURTIS JENSEN Other 510(k) Applications for this Contact
Regulation Number	884.4120   More FDA Info for this Regulation Number
Classification Product Code	HGI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2012
Decision Date	10/18/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review