SYSLOC MINI V3


Device Classification Name

needle, fistula

510(k) Number K110157
Device Name SYSLOC MINI V3
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 01/19/2011
Decision Date 02/11/2011
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