DeviceClearance

Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency +3 more— 510(k) K151470

Substantially Equivalent

First Quality Hygienic, Inc.

FDA 510(k) clearance K151470 for Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency +3 more, Substantially Equivalent on 2015-11-02. Applicant: First Quality Hygienic, Inc.. Device class: 2.

Clearance details

Device name as filed
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency
Applicant
First Quality Hygienic, Inc.
Product code
Code HEB
Device class
Class 2
Regulation
21 CFR 884.5470
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Mcelhattan, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HEB

product code HEB
Injury
329
Malfunction
5,647
Total
5,976

Source: openFDA MAUDE database, through . 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.