FDA 510(k) Application Details - K013889

Device Classification Name	More FDA Info for this Device
510(K) Number	K013889
Device Name	ENDOSCOPIC MULTI-FIRE CLIP APPLIER
Applicant	INSCOPE, LLC. 8210 NW 27TH ST. MIAMI, FL 33122 US Other 510(k) Applications for this Company
Contact	BRUCE WEBER 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	11/23/2001
Decision Date	02/07/2002
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