The following data is part of a premarket notification filed by Osstell Ab with the FDA for Mega Isq.
| Device ID | K132401 |
| 510k Number | K132401 |
| Device Name: | MEGA ISQ |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | OSSTELL AB 901 KING STREET SUITE 101 Alexandria, VA 22314 |
| Contact | Cherita James |
| Correspondent | Cherita James OSSTELL AB 901 KING STREET SUITE 101 Alexandria, VA 22314 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-01 |
| Decision Date | 2014-04-09 |
| Summary: | summary |