FDA 510(k) Application Details - K113697

Device Classification Name	Light, Surgical, Fiberoptic   More FDA Info for this Device
510(K) Number	K113697
Device Name	Light, Surgical, Fiberoptic
Applicant	INVUITY, INC. 39 STILLMAN STREET SAN FRANCISO, CA 94107 US Other 510(k) Applications for this Company
Contact	THERESA BRANDNER-ALLEN Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FST Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2011
Decision Date	02/10/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review