The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Donaldson-type Vent Tube.
| Device ID | K832362 |
| 510k Number | K832362 |
| Device Name: | DONALDSON-TYPE VENT TUBE |
| Classification | Tube, Tympanostomy |
| Applicant | CONCEPT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-18 |
| Decision Date | 1983-10-14 |