The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Monoject 12ml Syringe.
| Device ID | K130049 |
| 510k Number | K130049 |
| Device Name: | MONOJECT 12ML SYRINGE |
| Classification | Syringe, Piston |
| Applicant | NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
| Contact | Jessica Oswald-mcleod |
| Correspondent | Jessica Oswald-mcleod NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-08 |
| Decision Date | 2013-02-14 |
| Summary: | summary |