The following data is part of a premarket notification filed by American Sleep Association with the FDA for Asa Oral Appliances.
| Device ID | K130504 |
| 510k Number | K130504 |
| Device Name: | ASA ORAL APPLIANCES |
| Classification | Device, Anti-snoring |
| Applicant | AMERICAN SLEEP ASSOCIATION PO BOX 566 Chesterland, OH 44026 -2141 |
| Contact | Karen E Warden, Phd |
| Correspondent | Karen E Warden, Phd AMERICAN SLEEP ASSOCIATION PO BOX 566 Chesterland, OH 44026 -2141 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-27 |
| Decision Date | 2013-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D156MO2 | K130504 | 000 |