The following data is part of a premarket notification filed by Endovations, Inc. with the FDA for Oxygen Mouthguard.
| Device ID | K944049 |
| 510k Number | K944049 |
| Device Name: | OXYGEN MOUTHGUARD |
| Classification | Endoscopic Bite Block |
| Applicant | ENDOVATIONS, INC. P.O. BOX 6386 HILL AND GEORGE AVEENUES Reading, PA 19610 |
| Contact | Ronald D Wolfe |
| Correspondent | Ronald D Wolfe ENDOVATIONS, INC. P.O. BOX 6386 HILL AND GEORGE AVEENUES Reading, PA 19610 |
| Product Code | MNK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-18 |
| Decision Date | 1994-10-11 |