Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014448321

FEI Number

3014448321

Entity Name

PURGO BIOLOGICS INC.

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

#812, 27, Dunchon-daero 457 beon-gil,Jungwon-gu, Seongnam-si Gyeonggi 13219, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PURGO BIOLOGICS Inc. (Owner Number: 10053793)

Owner / Operator Contact Address

#812, 27 Duncheon-daero, 457 beon-gil, Jungwon-gu, Seongnam-si, KR-41 13219, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180992

PMA Number

N/A

All Registered Proprietary Names

THE Cover THE Graft Collagen CYTOSHIELD OpenTex TBS PTFE Membrane Biotex TBS PTFE Suture

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2023-10-10
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2024-07-25
NPK	Barrier, Synthetic, Intraoral	Dental	Class 2	872.3930	2023-05-14
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2019-07-19

Official Correspondent

Byungsun Kim

US Agent Details

WONCHUL KIM Email: ra@purgobio.com Phone: (917) 9703064

Related Public Records

Same Entity

PURGO BIOLOGICS Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014448321. Last updated year: 2026. Please use registration number 3014448321 when referencing this establishment in official correspondence.