The following data is part of a premarket notification filed by Steven K. Sue with the FDA for Nose Breathe Mouthpiece For Heavy Snorer.
| Device ID | K013687 |
| 510k Number | K013687 |
| Device Name: | NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER |
| Classification | Device, Anti-snoring |
| Applicant | STEVEN K. SUE 2065 S. KING ST. SUITE 304 Honolulu, HI 96826 |
| Contact | Steven K Sue |
| Correspondent | Steven K Sue STEVEN K. SUE 2065 S. KING ST. SUITE 304 Honolulu, HI 96826 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-07 |
| Decision Date | 2002-05-28 |
| Summary: | summary |