JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET


Device Classification Name

catheter,intravascular,therapeutic,short-term less than 30 days

510(k) Number K030479
Device Name JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET
Applicant
JMS NORTH AMERICA CORP.
22320 foothill blvd.,
suite 350
hayward, 
CA 
94541

Applicant Contact swee cheau
Correspondent
JMS NORTH AMERICA CORP.
22320 foothill blvd.,
suite 350
hayward, 
CA 
94541

Correspodent Contact swee cheau
Regulation Number 880.5200
Classification Product Code
FOZ  
Date Received 02/13/2003
Decision Date 08/18/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No