The following data is part of a premarket notification filed by Altomed Limited with the FDA for Altomed Malhotra Platinum Segments.
| Device ID | K170591 |
| 510k Number | K170591 |
| Device Name: | Altomed Malhotra Platinum Segments |
| Classification | Weights, Eyelid, External |
| Applicant | Altomed Limited 2 Whitney Way Bolden Business Park Bolden, Tyne And Wear, GB Ne35 9pe |
| Contact | Stuart March |
| Correspondent | Stuart March Audrey Vitale LLC 2 Witney Way Tyne & Wear, GB |
| Product Code | MML |
| CFR Regulation Number | 886.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-28 |
| Decision Date | 2017-06-06 |
| Summary: | summary |