The following data is part of a premarket notification filed by Nti-tss, Inc. with the FDA for Nti Tension Suppression System, With A Snorehook Application.
| Device ID | K041184 |
| 510k Number | K041184 |
| Device Name: | NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION |
| Classification | Device, Anti-snoring |
| Applicant | NTI-TSS, INC. 5327 LA GLORIETA PO BX 2145 Rancho Santa Fe, CA 92067 -2145 |
| Contact | James Boyd |
| Correspondent | James Boyd NTI-TSS, INC. 5327 LA GLORIETA PO BX 2145 Rancho Santa Fe, CA 92067 -2145 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-06 |
| Decision Date | 2005-05-03 |