The following data is part of a premarket notification filed by Sontek Industries, Inc. with the FDA for Bodai Swivel Y.
| Device ID | K813324 |
| 510k Number | K813324 |
| Device Name: | BODAI SWIVEL Y |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | SONTEK INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-24 |
| Decision Date | 1981-12-29 |