The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Monoject 60ml Syringe (luer Lock Tip, Luer Slip Tip, Catheter Tip).
| Device ID | K131641 |
| 510k Number | K131641 |
| Device Name: | MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP) |
| Classification | Syringe, Piston |
| Applicant | NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Doral, FL 33172 |
| Contact | Jessica Oswald-mcleod |
| Correspondent | Jessica Oswald-mcleod NIPRO MEDICAL CORPORATION 3150 N.W. 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 | 2013-06-04 |
| Decision Date | 2013-08-28 |
| Summary: | summary |