Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026199504

FEI Number

3026199504

Entity Name

SHANDONG INTCO HYGIENE PRODUCTS CO., LTD.

City/State/Country

Zibo Shandong, CN

Establishment Address

Workshop C3, No. 29, Zhangliu Road, Fangzhen Town, Zhangdian District, Zibo Shandong 255095, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shandong Intco hygiene Products Co., Ltd. (Owner Number: 10086734)

Owner / Operator Contact Address

Workshop C3, No. 29, Zhangliu Road, Fangzhen Town, Zhangdian District, Zibo, CN-SD 255095, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241064

PMA Number

N/A

All Registered Proprietary Names

CARDBOARD APPLICATOR TAMPON Unscented Tampon with Plastic Applicators Unscented Tampon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2024-08-19
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2022-12-06
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2025-02-17

Official Correspondent

Max Li

US Agent Details

Max Li Business: Intco Medical Industries, Inc. Email: maxli@basicmedical.com Phone: (909) 9801678

Related Public Records

Same Entity

Shandong Intco hygiene Products Co., Ltd.

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
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026199504. Last updated year: 2026. Please use registration number 3026199504 when referencing this establishment in official correspondence.