The following data is part of a premarket notification filed by Oxequip Health Ind. with the FDA for Tri Pac Mouth Prop.
| Device ID | K800369 |
| 510k Number | K800369 |
| Device Name: | TRI PAC MOUTH PROP |
| Classification | Block, Bite |
| Applicant | OXEQUIP HEALTH IND. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JXL |
| CFR Regulation Number | 882.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-20 |
| Decision Date | 1980-02-28 |