SUPER SOOTHER— 510(k) K991914

Substantially Equivalent

Mart Tiller Corp.

FDA 510(k) clearance K991914 for SUPER SOOTHER, Substantially Equivalent on 1999-10-06. Applicant: Mart Tiller Corp..

Clearance details

Applicant: Mart Tiller Corp.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1999-06-07
Decision date: 1999-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.