The following data is part of a premarket notification filed by Hyman, Phelps & Mcnamara, P.c. with the FDA for Menicon Sp Vial.
| Device ID | K950878 |
| 510k Number | K950878 |
| Device Name: | MENICON SP VIAL |
| Classification | Case, Contact Lens |
| Applicant | Hyman, Phelps & McNamara, P.C. 700 13TH ST. N.W. STE. 1200 Washington, DC 20005 -5929 |
| Contact | A. W Siegner, Jr. |
| Correspondent | A. W Siegner, Jr. Hyman, Phelps & McNamara, P.C. 700 13TH ST. N.W. STE. 1200 Washington, DC 20005 -5929 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-28 |
| Decision Date | 1995-04-07 |