FEMTEX GENTLE TOUCH TAMPONS— 510(k) K963034
Substantially EquivalentFirst Quality Hygienic, Inc.
FDA 510(k) clearance K963034 for FEMTEX GENTLE TOUCH TAMPONS, Substantially Equivalent on 1996-11-01. Applicant: First Quality Hygienic, Inc.. Device class: 2.
Clearance details
- 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
- Traditional
- Location
- Allendale, NJ, US
Recent devices under product code HEB
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view all- K161877 — Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl
- K151470 — Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency +3 more
- K051446 — FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS
- K050660 — FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
- K050067 — FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
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.