The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Oberto Mouth Prop.
| Device ID | K864962 |
| 510k Number | K864962 |
| Device Name: | OBERTO MOUTH PROP |
| Classification | Block, Bite |
| Applicant | MEDOVATIONS, INC. 102 EAST KEEFE AVE. Milwaukee, WI 53212 |
| Contact | Larry R Pierce |
| Correspondent | Larry R Pierce MEDOVATIONS, INC. 102 EAST KEEFE AVE. Milwaukee, WI 53212 |
| Product Code | JXL |
| CFR Regulation Number | 882.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-22 |
| Decision Date | 1987-02-19 |