The following data is part of a premarket notification filed by Ortho-tain, Inc. with the FDA for Snore-cure Anti-snoring Appliance.
| Device ID | K980952 |
| 510k Number | K980952 |
| Device Name: | SNORE-CURE ANTI-SNORING APPLIANCE |
| Classification | Device, Anti-snoring |
| Applicant | ORTHO-TAIN, INC. 600 13TH ST., N.W. Washington, DC 20005 |
| Contact | David L Rosen |
| Correspondent | David L Rosen ORTHO-TAIN, INC. 600 13TH ST., N.W. Washington, DC 20005 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-13 |
| Decision Date | 1998-06-01 |
| Summary: | summary |