The following data is part of a premarket notification filed by Institute For Quality Resource Management with the FDA for Ndx Dorsal Appliance.
| Device ID | K133390 |
| 510k Number | K133390 |
| Device Name: | NDX DORSAL APPLIANCE |
| Classification | Device, Anti-snoring |
| Applicant | INSTITUTE FOR QUALITY RESOURCE MANAGEMENT 1 CITY PLACE DRIVE, STE 285 St. Louis, MO 63131 |
| Contact | Leah Amir, Ms, Mha |
| Correspondent | Leah Amir, Ms, Mha INSTITUTE FOR QUALITY RESOURCE MANAGEMENT 1 CITY PLACE DRIVE, STE 285 St. Louis, MO 63131 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-05 |
| Decision Date | 2014-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860313000803 | K133390 | 000 |