The following data is part of a premarket notification filed by Nissho Corp. with the FDA for Nipro Branded Disposable Syringes, Needles.
| Device ID | K944355 |
| 510k Number | K944355 |
| Device Name: | NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES |
| Classification | Syringe, Piston |
| Applicant | NISSHO CORP. 7205 CORPORATE CENTER DR. # 305 Miami, FL 33126 |
| Contact | Louis Candelario |
| Correspondent | Louis Candelario NISSHO CORP. 7205 CORPORATE CENTER DR. # 305 Miami, FL 33126 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-07 |
| Decision Date | 1994-12-07 |