The following data is part of a premarket notification filed by Nti-tss, Inc. with the FDA for Nti Tension Suppression System.
| Device ID | K010876 |
| 510k Number | K010876 |
| Device Name: | NTI TENSION SUPPRESSION SYSTEM |
| Classification | Mouthguard, Migraine/tension Headache |
| Applicant | NTI-TSS, INC. 2303 BLUE SMOKE TRAIL Mishawaka, IN 46544 |
| Contact | Bob Weber |
| Correspondent | Bob Weber NTI-TSS, INC. 2303 BLUE SMOKE TRAIL Mishawaka, IN 46544 |
| Product Code | OCO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-23 |
| Decision Date | 2001-06-20 |