FDA 510(k) Application Details - K150718

Device Classification Name Ligator, Hemorrhoidal

  More FDA Info for this Device
510(K) Number K150718
Device Name Ligator, Hemorrhoidal
Applicant AGENCY FOR MEDICAL INNOVATIONS GMBH
IM LETTEN 1
FELDKIRCH, VORARLBERG 6800 AT
Other 510(k) Applications for this Company
Contact Stefanie Hoellger
Other 510(k) Applications for this Contact
Regulation Number 876.4400

  More FDA Info for this Regulation Number
Classification Product Code FHN
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 03/19/2015
Decision Date 06/12/2015
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact