The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Micromedics Fibrijet Aerosol Applicator.
| Device ID | K012868 |
| 510k Number | K012868 |
| Device Name: | MICROMEDICS FIBRIJET AEROSOL APPLICATOR |
| Classification | Syringe, Piston |
| Applicant | MICROMEDICS, INC. 1285 CORPORATE CENTER DR., #150 Eagan, MN 55121 |
| Contact | Charles Grote |
| Correspondent | Charles Grote MICROMEDICS, INC. 1285 CORPORATE CENTER DR., #150 Eagan, MN 55121 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-27 |
| Decision Date | 2001-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888867001982 | K012868 | 000 |
| 10888867001975 | K012868 | 000 |
| 10888867001968 | K012868 | 000 |