The following data is part of a premarket notification filed by Te Me Na S.a.r.l. with the FDA for Te Me Na Loss Of Resistance Syringe, 10cc.
| Device ID | K990020 |
| 510k Number | K990020 |
| Device Name: | TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC |
| Classification | Syringe, Piston |
| Applicant | TE ME NA S.A.R.L. 21981 U.S. 19N Clearwater, FL 33765 |
| Contact | Donald F Ryan |
| Correspondent | Donald F Ryan TE ME NA S.A.R.L. 21981 U.S. 19N Clearwater, FL 33765 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-04 |
| Decision Date | 1999-06-24 |