The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Bite Stick.
| Device ID | K821177 |
| 510k Number | K821177 |
| Device Name: | BITE STICK |
| Classification | Depressor, Tongue, Non-surgical |
| Applicant | ABCO DEALERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMA |
| CFR Regulation Number | 880.6230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-27 |
| Decision Date | 1982-05-21 |