The following data is part of a premarket notification filed by Otomedics Advanced Medical Technologies, Ltd. with the FDA for Otomedics Soft Tympanostomy Tube.
| Device ID | K071178 |
| 510k Number | K071178 |
| Device Name: | OTOMEDICS SOFT TYMPANOSTOMY TUBE |
| Classification | Tube, Tympanostomy |
| Applicant | OTOMEDICS ADVANCED MEDICAL TECHNOLOGIES, LTD. 20 HATA'AS ST. Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein OTOMEDICS ADVANCED MEDICAL TECHNOLOGIES, LTD. 20 HATA'AS ST. Kfar Saba, IL 44425 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-27 |
| Decision Date | 2007-06-22 |
| Summary: | summary |