The following data is part of a premarket notification filed by Medone Surgical, Inc. with the FDA for Microdose Injector.
| Device ID | K203264 |
| 510k Number | K203264 |
| Device Name: | MicroDose Injector |
| Classification | Syringe, Piston |
| Applicant | MedOne Surgical, Inc. 670 Tallevast Road Sarasota, FL 34243 |
| Contact | Bruce Beckstein |
| Correspondent | Darla Elkin Elkin RC, LLC 42 North Chantsong Circle The Woodlands, TX 77382 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-05 |
| Decision Date | 2021-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811313012754 | K203264 | 000 |
| 00811313013157 | K203264 | 000 |