The following data is part of a premarket notification filed by Covidien with the FDA for Micromyst Applicator, Model 20-5000.
| Device ID | K082454 |
| 510k Number | K082454 |
| Device Name: | MICROMYST APPLICATOR, MODEL 20-5000 |
| Classification | Syringe, Piston |
| Applicant | COVIDIEN 101A FIRST AVE Waltham, MA 02451 |
| Contact | Virginia Vetter |
| Correspondent | Virginia Vetter COVIDIEN 101A FIRST AVE Waltham, MA 02451 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-26 |
| Decision Date | 2008-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30381780000116 | K082454 | 000 |