The following data is part of a premarket notification filed by Selane Products, Inc. with the FDA for Atg/sm-osa Appliances.
| Device ID | K130130 |
| 510k Number | K130130 |
| Device Name: | ATG/SM-OSA APPLIANCES |
| Classification | Device, Jaw Repositioning |
| Applicant | SELANE PRODUCTS, INC. 7046 OWL'S NEST TERRACE Bradenton, FL 34203 |
| Contact | Carolyn Primus |
| Correspondent | Carolyn Primus SELANE PRODUCTS, INC. 7046 OWL'S NEST TERRACE Bradenton, FL 34203 |
| Product Code | LQZ |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-17 |
| Decision Date | 2013-08-26 |
| Summary: | summary |