FDA 510(k) Application Details - K120373

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K120373
Device Name	Staple, Implantable
Applicant	INCISIVE SURGICAL, INC. 14405 21ST AVE N. SUITE 130 PLYMOUTH, MN 55447 US Other 510(k) Applications for this Company
Contact	DAVID HERRIDGE Other 510(k) Applications for this Contact
Regulation Number	878.4750   More FDA Info for this Regulation Number
Classification Product Code	GDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/06/2012
Decision Date	03/16/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review