FDA 510(k) Application Details - K061651

Device Classification Name	Electrocautery, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K061651
Device Name	Electrocautery, Gynecologic (And Accessories)
Applicant	APPLE MEDICAL CORP. 28 LORD RD., UNIT 135 MARLBORO, MA 01752 US Other 510(k) Applications for this Company
Contact	JOHN C PULFORD 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	06/13/2006
Decision Date	10/20/2006
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