The following data is part of a premarket notification filed by Octostop, Inc. with the FDA for The Pharaoh Compensating Filter.
| Device ID | K963941 |
| 510k Number | K963941 |
| Device Name: | THE PHARAOH COMPENSATING FILTER |
| Classification | System, X-ray, Stationary |
| 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 | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-01 |
| Decision Date | 1996-11-27 |