The following data is part of a premarket notification filed by Bio-med Usa Inc with the FDA for Unitox Botox Syringe.
| Device ID | K123710 |
| 510k Number | K123710 |
| Device Name: | UNITOX BOTOX SYRINGE |
| Classification | Syringe, Piston |
| Applicant | BIO-MED USA INC 111 ELLISON STREET Paterson, NJ 07505 |
| Contact | Young Chi |
| Correspondent | Young Chi BIO-MED USA INC 111 ELLISON STREET Paterson, NJ 07505 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-04 |
| Decision Date | 2013-05-09 |
| Summary: | summary |