FDA 510(k) Application Details - K133499

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K133499
Device Name	Staple, Implantable
Applicant	SUZHOU BEINUO MEDICAL EQUIPMENT CO. LTD. 816 CONGRESS AVE., STE 1400 AUSTIN, TX 78701 US Other 510(k) Applications for this Company
Contact	ROBERT SEIPLE, RAC 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	11/14/2013
Decision Date	01/14/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review