FDA 510(k) Application Details - K062475

Device Classification Name Lithotriptor, Electro-Hydraulic

  More FDA Info for this Device
510(K) Number K062475
Device Name Lithotriptor, Electro-Hydraulic
Applicant THE LARYNGEAL MASK CO.,LTD.
4660 LA JOLLA VILLAGE DRIVE
SAN DIEGO, CA 92122 US
Other 510(k) Applications for this Company
Contact FOSTER BOOP
Other 510(k) Applications for this Contact
Regulation Number 876.4480

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

  More FDA Info for this Product Code
Date Received 08/24/2006
Decision Date 05/09/2007
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