The following data is part of a premarket notification filed by Jms North America Corp. with the FDA for Jms Sysloc A.v. Fistula Needle Set, Jms Sysloc Apheresis Needle Set.
| Device ID | K030479 |
| 510k Number | K030479 |
| Device Name: | JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | JMS NORTH AMERICA CORP. 22320 FOOTHILL BLVD., SUITE 350 Hayward, CA 94541 |
| Contact | Swee Cheau |
| Correspondent | Swee Cheau JMS NORTH AMERICA CORP. 22320 FOOTHILL BLVD., SUITE 350 Hayward, CA 94541 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-13 |
| Decision Date | 2003-08-18 |