The following data is part of a premarket notification filed by Microsurgical Technologies Inc with the FDA for Trabex Pro.
| Device ID | K213173 |
| 510k Number | K213173 |
| Device Name: | TrabEx Pro |
| Classification | Pump, Infusion, Ophthalmic |
| Applicant | MicroSurgical Technologies Inc 8415 154th Ave NE Redmond, WA 98052 |
| Contact | Angela Mallery |
| Correspondent | Angela Mallery MicroSurgical Technologies Inc 8415 154th Ave NE Redmond, WA 98052 |
| Product Code | MRH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-28 |
| Decision Date | 2022-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844685009381 | K213173 | 000 |