The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Respironics Custom Ii Oral Appliance.
| Device ID | K033823 |
| 510k Number | K033823 |
| Device Name: | RESPIRONICS CUSTOM II ORAL APPLIANCE |
| Classification | Device, Anti-snoring |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Zita A Yurko |
| Correspondent | Zita A Yurko RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-10 |
| Decision Date | 2004-02-06 |
| Summary: | summary |