The following data is part of a premarket notification filed by Octostop, Inc. with the FDA for Octoroll.
| Device ID | K953246 |
| 510k Number | K953246 |
| Device Name: | OCTOROLL |
| Classification | Cradle, Patient, Radiologic |
| Applicant | OCTOSTOP, INC. 3575 BOUL. ST-LAURENT BUREAU 401 NT Montreal, H2x2t7, CA |
| Contact | Sylvain Boucher |
| Correspondent | Sylvain Boucher OCTOSTOP, INC. 3575 BOUL. ST-LAURENT BUREAU 401 NT Montreal, H2x2t7, CA |
| Product Code | KXH |
| CFR Regulation Number | 892.1830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-11 |
| Decision Date | 1995-09-29 |