The following data is part of a premarket notification filed by Octostop, Inc. with the FDA for Pivoting Compensating Filters For The Head.
| Device ID | K972766 |
| 510k Number | K972766 |
| Device Name: | PIVOTING COMPENSATING FILTERS FOR THE HEAD |
| Classification | System, X-ray, Stationary |
| Applicant | OCTOSTOP, INC. CASIER POSTAL 1476 SUCC. ST-LAURENT Montreal, Qc., CA H4l 4z1 |
| Contact | Jean A Venzina |
| Correspondent | Jean A Venzina 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 | 1997-07-24 |
| Decision Date | 1997-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B525FI03A0 | K972766 | 000 |
| B525FI030 | K972766 | 000 |