The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Ent Shavers.
| Device ID | K081814 |
| 510k Number | K081814 |
| Device Name: | REPROCESSED ENT SHAVERS |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | STERILMED, INC. 11400 73RD AVE. N, STE. 100 Maple Grove, MN 55369 |
| Contact | Joshua Clarin |
| Correspondent | Joshua Clarin STERILMED, INC. 11400 73RD AVE. N, STE. 100 Maple Grove, MN 55369 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-26 |
| Decision Date | 2008-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551025171 | K081814 | 000 |
| 10888551019606 | K081814 | 000 |
| 10888551019613 | K081814 | 000 |
| 10888551019620 | K081814 | 000 |
| 10888551019637 | K081814 | 000 |
| 10888551025058 | K081814 | 000 |
| 10888551025065 | K081814 | 000 |
| 10888551025072 | K081814 | 000 |
| 10888551025089 | K081814 | 000 |
| 10888551025096 | K081814 | 000 |
| 10888551025102 | K081814 | 000 |
| 10888551025119 | K081814 | 000 |
| 10888551025126 | K081814 | 000 |
| 10888551025133 | K081814 | 000 |
| 10888551025140 | K081814 | 000 |
| 10888551025157 | K081814 | 000 |
| 10888551025164 | K081814 | 000 |
| 10888551019590 | K081814 | 000 |