The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Earpopper, Model Ep-2000, Ep-2100, Ep-3000.
| Device ID | K073401 |
| 510k Number | K073401 |
| Device Name: | EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 |
| Classification | Device, Inflation, Middle Ear |
| Applicant | MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD SUITE 120 Eagan, MN 55121 |
| Contact | Tom Lopac |
| Correspondent | Tom Lopac MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD SUITE 120 Eagan, MN 55121 |
| Product Code | MJV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-04 |
| Decision Date | 2008-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00385640023870 | K073401 | 000 |
| 00385640023863 | K073401 | 000 |
| 00385640023849 | K073401 | 000 |
| 00385640002424 | K073401 | 000 |
| 00385640002431 | K073401 | 000 |