The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Tympanostomy Tube.
| Device ID | K082188 |
| 510k Number | K082188 |
| Device Name: | TYMPANOSTOMY TUBE |
| Classification | Tube, Tympanostomy |
| Applicant | ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Keri Yen |
| Correspondent | Keri Yen ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-04 |
| Decision Date | 2008-09-19 |
| Summary: | summary |