Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000247987

FEI Number

3000247987

Entity Name

SEWOON MEDICAL CO., LTD.

City/State/Country

Cheonan-si Chungnam, KR

Establishment Address

60, Dorim-gil, Ipjang-myeon, Seobuk-gu,, Cheonan-si Chungnam 31061, KR

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SEWOON Medical Co., Ltd. (Owner Number: 9036109)

Owner / Operator Contact Address

60 Dorim-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, KR-44 31061, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K022287

PMA Number

N/A

All Registered Proprietary Names

Barovac Bonastent Bonastent Barovac Barovac Temp Foley

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	1999-01-08
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2021-09-23
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2012-05-10
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2012-05-10
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2008-12-04
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	1999-01-08
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2008-01-16

Official Correspondent

Jaehee Lee

US Agent Details

SOOJUNG MOON Business: Allura Medical Solution Inc. Email: sjmoon@allurameds.com Phone: (407) 2429796

Related Public Records

Same Entity

SEWOON Medical 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
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K902734	Olympus Corp.	PR CANNULAS	1990-08-22
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000247987. Last updated year: 2026. Please use registration number 3000247987 when referencing this establishment in official correspondence.