NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION— 510(k) K041184

Substantially Equivalent

Nti-Tss, Inc.

FDA 510(k) clearance K041184 for NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION, Substantially Equivalent on 2005-05-03. Applicant: Nti-Tss, Inc..

Clearance details

Applicant: Nti-Tss, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 2004-05-06
Decision date: 2005-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa Fe, CA, US

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Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.