The following data is part of a premarket notification filed by Top Corporation with the FDA for 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe.
| Device ID | K182765 |
| 510k Number | K182765 |
| Device Name: | 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe |
| Classification | Syringe, Piston |
| Applicant | TOP Corporation 19-10 Senju Nakai-cho Adachi-ku, JP 120-0035 |
| Contact | Sho Yokoya |
| Correspondent | Jonathan Gilbert Jon Gilbert 1641 Jeurissen Lane Chanhassen, MN 55317 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2019-09-03 |
| Summary: | summary |