Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016445763

FEI Number

3016445763

Entity Name

SKIDYWORKS INTERNATIONAL CO., LTD

City/State/Country

JEJU, KR

Establishment Address

#406 AFE Globaledu-ro 396-0, Daejeong - eup, Seogwipo-si, JEJU 63644, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SKIDYWORKS INTERNATIONAL CO., LTD (Owner Number: 10062402)

Owner / Operator Contact Address

#106, 301-26 Pyeonghwa-ro 89beon-gil,, Daejeong - eup, Seogwipo-si, JEJU, KR-NOTA 63519, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CANNULA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-01-22

Official Correspondent

Clive Seo

US Agent Details

Michael Grillo Business: CosmoFrance Email: regulatory@cosmofrance.net Phone: (305) 5380110

Related Public Records

Same Entity

SKIDYWORKS INTERNATIONAL 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
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016445763. Last updated year: 2026. Please use registration number 3016445763 when referencing this establishment in official correspondence.