The following data is part of a premarket notification filed by Meta Biomed, Inc. with the FDA for Endo Smart.
| Device ID | K133298 |
| 510k Number | K133298 |
| Device Name: | ENDO SMART |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | META BIOMED, INC. 2600 MULLINIX MILL ROAD Mt. Airy, MD 21771 |
| Contact | Blix Winston |
| Correspondent | Blix Winston META BIOMED, INC. 2600 MULLINIX MILL ROAD Mt. Airy, MD 21771 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-25 |
| Decision Date | 2014-09-19 |
| Summary: | summary |