FDA 510(k) Application Details - K101428

Device Classification Name	More FDA Info for this Device
510(K) Number	K101428
Device Name	OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET
Applicant	OVESCO ENDOSCOPY AG KASTELLSTR. 8 BADEN WUERTTEMBERG KARLSRUHE 76227 DE Other 510(k) Applications for this Company
Contact	ARNE BRIEST Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2010
Decision Date	12/01/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review