FDA 510(k) Application Details - K092421

Device Classification Name	Hysteroscope (And Accessories)   More FDA Info for this Device
510(K) Number	K092421
Device Name	Hysteroscope (And Accessories)
Applicant	GIMMI GMBH ONE SCANLAN PLAZA SAINT PAUL, MN 55107 US Other 510(k) Applications for this Company
Contact	KEN BLAKE Other 510(k) Applications for this Contact
Regulation Number	884.1690   More FDA Info for this Regulation Number
Classification Product Code	HIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2009
Decision Date	02/12/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review