The following data is part of a premarket notification filed by Unique Management Ent., Inc. with the FDA for Unique Needle With Firm Grip Shield.
| Device ID | K950666 |
| 510k Number | K950666 |
| Device Name: | UNIQUE NEEDLE WITH FIRM GRIP SHIELD |
| Classification | Syringe, Piston |
| Applicant | UNIQUE MANAGEMENT ENT., INC. 209 SCHOOLHOUSE RD. Albany, NY 12203 -5956 |
| Contact | Thomas E Ferari |
| Correspondent | Thomas 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 | 1995-02-13 |
| Decision Date | 1996-02-16 |