The following data is part of a premarket notification filed by Octostop, Inc. with the FDA for Octopaque Universal.
| Device ID | K942916 |
| 510k Number | K942916 |
| Device Name: | OCTOPAQUE UNIVERSAL |
| Classification | Table, Radiographic, Stationary Top |
| Applicant | OCTOSTOP, INC. CASIER POSTAL 1476 SUCC. ST-LAURENT Montreal, Qc., CA H4l 4z1 |
| Contact | Jean A Vezina, M.d. |
| Correspondent | Jean A Vezina, M.d. OCTOSTOP, INC. CASIER POSTAL 1476 SUCC. ST-LAURENT Montreal, Qc., CA H4l 4z1 |
| Product Code | IXQ |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-21 |
| Decision Date | 1994-09-08 |