The following data is part of a premarket notification filed by Entreprises Octostop, Inc. with the FDA for Boomerang Absorption Comensation Filter.
| Device ID | K853330 |
| 510k Number | K853330 |
| Device Name: | BOOMERANG ABSORPTION COMENSATION FILTER |
| Classification | System, X-ray, Stationary |
| Applicant | ENTREPRISES OCTOSTOP, INC. C.P. 1476 ST. LAURENT Montreal, Canada H4l 421, CA |
| Contact | Jean A Vezina |
| Correspondent | Jean A Vezina ENTREPRISES OCTOSTOP, INC. C.P. 1476 ST. LAURENT Montreal, Canada H4l 421, CA |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-08 |
| Decision Date | 1985-11-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B525FI01NC0 | K853330 | 000 |
| B525FI01A0 | K853330 | 000 |
| B525FI010 | K853330 | 000 |