WINGEATER V2


Device Classification Name

needle, fistula

510(k) Number K111948
Device Name WINGEATER V2
Applicant
JMS NORTH AMERICA CORPORATION
1468 harwell ave.
crofton, 
MD 
21114

Applicant Contact e j smith
Correspondent
JMS NORTH AMERICA CORPORATION
1468 harwell ave.
crofton, 
MD 
21114

Correspodent Contact e j smith
Regulation Number 876.5540
Classification Product Code
FIE  
Date Received 07/08/2011
Decision Date 10/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No