Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009803802

FEI Number

3009803802

Entity Name

MODEL SOLUTION

City/State/Country

Bucheon-si Gyeonggi, KR

Establishment Address

14 , Saneop-ro, 104 Beon-gil, Bucheon-si Gyeonggi 14402, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Model Solution (Owner Number: 10057287)

Owner / Operator Contact Address

14, Saneop-ro, 104 Beon-gil, Bucheon-si, KR-41 14402, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tandem Mobi Adhesive Sleeve

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-01-04

Official Correspondent

Sunghwan Kim

US Agent Details

Calvin Pak Business: Calvin Pak Email: info@model-solution.com Phone: (408) 3202220

Related Public Records

Same Entity

Model Solution

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
3019843433	The Natural Patch Company Pty Ltd	Prahran Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009803802. Last updated year: 2026. Please use registration number 3009803802 when referencing this establishment in official correspondence.