FIRST TOUCH/VILEDON NON-WOVEN FILTER— 510(k) K915752

Substantially Equivalent

First Touch Disposables, Inc.

FDA 510(k) clearance K915752 for FIRST TOUCH/VILEDON NON-WOVEN FILTER, Substantially Equivalent on 1992-09-17. Applicant: First Touch Disposables, Inc..

Clearance details

Applicant: First Touch Disposables, Inc.
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 1991-12-23
Decision date: 1992-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, NC, US

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Adverse events under product code FMZ

product code FMZ

Death: 2
Malfunction: 457
Other: 1
Total: 460

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.