The following data is part of a premarket notification filed by Jms North America Corporation with the FDA for Jms Syringe.
| Device ID | K132321 |
| 510k Number | K132321 |
| Device Name: | JMS SYRINGE |
| Classification | Syringe, Piston |
| Applicant | JMS NORTH AMERICA CORPORATION 22320 FOOTHILL BLVD SUITE 350 Hayward, CA 94541 |
| Contact | Sho Hosoki |
| Correspondent | Sho Hosoki JMS NORTH AMERICA CORPORATION 22320 FOOTHILL BLVD SUITE 350 Hayward, CA 94541 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-25 |
| Decision Date | 2014-02-20 |
| Summary: | summary |