The following data is part of a premarket notification filed by Octostop, Inc. with the FDA for Accessory To Universal Octopaque.
| Device ID | K930357 |
| 510k Number | K930357 |
| Device Name: | ACCESSORY TO UNIVERSAL OCTOPAQUE |
| Classification | Cradle, Patient, Radiologic |
| Applicant | OCTOSTOP, INC. CASIER POSTAL 1476 SUCC. ST-LAURENT Montreal, Qc., CA H4l 4z1 |
| Contact | Jean A Vezina |
| Correspondent | Jean A Vezina OCTOSTOP, INC. CASIER POSTAL 1476 SUCC. ST-LAURENT Montreal, Qc., CA H4l 4z1 |
| Product Code | KXH |
| CFR Regulation Number | 892.1830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-26 |
| Decision Date | 1993-07-13 |