The following data is part of a premarket notification filed by Jms North America Corp. with the FDA for Plume Safety Avf Needle.
| Device ID | K040247 |
| 510k Number | K040247 |
| Device Name: | PLUME SAFETY AVF NEEDLE |
| Classification | Needle, Fistula |
| Applicant | JMS NORTH AMERICA CORP. 22320 FOOTHILL BLVD., SUITE 350 Hayward, CA 94541 |
| Contact | Chong Swee Cheau |
| Correspondent | Chong Swee Cheau JMS NORTH AMERICA CORP. 22320 FOOTHILL BLVD., SUITE 350 Hayward, CA 94541 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-03 |
| Decision Date | 2004-03-03 |