The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Acclarent Tympanostomy Tube And Tympanostomy Tube Delivery System.
| Device ID | K103595 |
| 510k Number | K103595 |
| Device Name: | ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM |
| Classification | Tube, Tympanostomy |
| Applicant | ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Gurvinder Singh Nanda |
| Correspondent | Gurvinder Singh Nanda 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 | 2010-12-08 |
| Decision Date | 2011-04-01 |
| Summary: | summary |