The following data is part of a premarket notification filed by Unique Management Ent., Inc. with the FDA for Unique Needle.
| Device ID | K950245 |
| 510k Number | K950245 |
| Device Name: | UNIQUE NEEDLE |
| Classification | Syringe, Piston |
| Applicant | UNIQUE MANAGEMENT ENT., INC. 209 SCHOOLHOUSE RD. Albany, NY 12203 -5956 |
| Contact | Thomnas E Ferari |
| Correspondent | Thomnas E Ferari UNIQUE MANAGEMENT ENT., INC. 209 SCHOOLHOUSE RD. Albany, NY 12203 -5956 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-20 |
| Decision Date | 1995-12-06 |