The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Tympanostomy Tubes-various.
| Device ID | K833246 |
| 510k Number | K833246 |
| Device Name: | TYMPANOSTOMY TUBES-VARIOUS |
| Classification | Tube, Tympanostomy |
| Applicant | ABCO DEALERS, 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 | 1983-09-08 |
| Decision Date | 1985-01-04 |