Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1648563

FEI Number

3000205942

Entity Name

SEVENTH GENERATION

City/State/Country

BTV, VT, US

Establishment Address

60 LAKE ST., BTV, VT 05401, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

SEVENTH GENERATION Inc. (Owner Number: 9024698)

Owner / Operator Contact Address

60 LAKE ST., --, Burlington, VT 05401, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K983478

PMA Number

N/A

All Registered Proprietary Names

Pad Maxi Overnight with Wings Pad Ultrathin Overnight with Wings Pad Maxi Regular (no wings) Pad Ultrathin Regular with Wings Pantiliner Pad Ultrathin Super Long with Wings Seventh Generation Organic Cotton Comfort Applicator Tampons, Super Seventh Generation Organic Cotton Comfort Applicator Tampons, Regular Seventh Generation Organic Cotton Applicator Tampons, Super Seventh Generation Organic Cotton Tampons, Super no applicator Seventh Generation Organic Cotton Tampons, Super Plus no applicator Seventh Generation Organic Cotton Tampons, Regular no applicator Seventh Generation Organic Cotton Applicator Tampons, Regular SEVENTH GENERATION ORGANIC ESSENTIALS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2021-07-12
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2018-01-10
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2018-01-10
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2000-08-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SEVENTH GENERATION Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28
K923985	Personal Products Co.	UNSCENTED MENSTRUAL TAMPON	1993-02-19
K151170	Tosama, D.O.O.	Tosama 100% Organic Cotton Menstrual Tampon	2015-07-02
K930149	Kimberly-Clark Corp.	KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+	1994-03-02

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3017366514	FIBRIL TEX PVT LTD.	Amritsar Punjab, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1648563. Last updated year: 2026. Please use registration number 1648563 when referencing this establishment in official correspondence.