The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Abont Syringe.
| Device ID | K212677 |
| 510k Number | K212677 |
| Device Name: | AboNT SYRINGE |
| Classification | Syringe, Piston |
| Applicant | Nipro Medical Corporation 3150 NW 107th Ave Doral, FL 33172 |
| Contact | Jessica Oswald-mcleod |
| Correspondent | Jessica Oswald-mcleod Nipro Medical Corporation 3150 NW 107th Ave Doral, FL 33172 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-24 |
| Decision Date | 2022-04-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ABONT SYRINGE 79305222 not registered Live/Pending |
Galderma S.A. 2021-01-09 |