Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K130368
Device Classification Name
Lithotriptor, Electro-Hydraulic
More FDA Info for this Device
510(K) Number
K130368
Device Name
Lithotriptor, Electro-Hydraulic
Applicant
NORTHGATE TECHNOLOGIES INC.
1591 SCOTTSDALE COURT
ELGIN, IL 60123 US
Other 510(k) Applications for this Company
Contact
CASEY KUREK
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
02/14/2013
Decision Date
11/15/2013
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