The following data is part of a premarket notification filed by Octostop, Inc. with the FDA for Ridges Plus.
| Device ID | K952871 |
| 510k Number | K952871 |
| Device Name: | RIDGES PLUS |
| Classification | System, X-ray, Stationary |
| Applicant | OCTOSTOP, INC. 6900 JEAN-BOURDON Montreal, Quebec, CA H4k 1g6 |
| Contact | Jean A Viezina |
| Correspondent | Jean A Viezina OCTOSTOP, INC. 6900 JEAN-BOURDON Montreal, Quebec, CA H4k 1g6 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-30 |
| Decision Date | 1995-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B525ST050 | K952871 | 000 |
| B525FI09C0 | K952871 | 000 |
| B525FI09B0 | K952871 | 000 |
| B525FI09A0 | K952871 | 000 |
| B525FI090 | K952871 | 000 |