The following data is part of a premarket notification filed by Santa Barbara Medco, Inc. with the FDA for Otological Ventilation Tubes.
| Device ID | K802638 |
| 510k Number | K802638 |
| Device Name: | OTOLOGICAL VENTILATION TUBES |
| Classification | Tube, Tympanostomy |
| Applicant | SANTA BARBARA MEDCO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-22 |
| Decision Date | 1980-11-12 |