FDA 510(k) Application Details - K103326

Device Classification Name	Instrument, Biopsy, Suction   More FDA Info for this Device
510(K) Number	K103326
Device Name	Instrument, Biopsy, Suction
Applicant	UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. MENTOR, OH 44060 US Other 510(k) Applications for this Company
Contact	CARROLL L MARTIN Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	FCK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2010
Decision Date	04/06/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review