The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Tympanostomy Tubes & Various Types.
| Device ID | K822017 |
| 510k Number | K822017 |
| Device Name: | TYMPANOSTOMY TUBES & VARIOUS TYPES |
| Classification | Tube, Tympanostomy |
| Applicant | KELLEHER CORP. 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 | 1982-07-08 |
| Decision Date | 1982-10-27 |