Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680646

FEI Number

1000582923

Entity Name

O&M Halyard Honduras S.A de C.V.

City/State/Country

VILLANEVA Cortes, HN

Establishment Address

CARRETERA TEGUCIGALPA,, VILLANEVA Cortes --, HN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

O&M Halyard, Inc. (Owner Number: 10057479)

Owner / Operator Contact Address

1220 Old Alpharetta Rd, Suite 320, Alpharetta, GA 30005, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210688

PMA Number

N/A

All Registered Proprietary Names

SURGICAL GOWN AERO BLUE SURGICAL GOWN SURGICAL GOWN GOWN, DRAPE PACKS SURGICAL DRAPE HALYARD ISOLATION SURGICAL GOWN Aero Blue Performance Surgical Gowns Aero Chrome Breathable Performance Surgical Gown HALYARD BASICS SURGICAL GOWN SURGICAL GOWN Aero Chrome Select

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-05-02
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-05-02
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2018-05-02
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-05-02
FYC	Gown, Isolation, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-05-02
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-12-23
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-04-27
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-17
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-05-18
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-05-02
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-08-13

Official Correspondent

Angela Bunn

US Agent Details

Angela Bunn Business: O&M HALYARD, INC. Email: angela.bunn@owens-minor.com Phone: (770) 4011697

Related Public Records

Same Entity

O&M Halyard, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012143814	Southaven Distribution Center	Southaven, MS, US
3016849443	O&M Halyard, Inc. (La Ada de Acuna)	Del Rio, TX, US
1054380	Halyard North Carolina, LLC	LINWOOD, NC, US
3035642068	Honduras Kitting, S.A.	Villanueva Cortes, HN
3005997949	La Ada De Acuna, S. de. R. L. de C. V.	COL.EDUCATIVA,NOGALES Sonora, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19

Similar Registrations

Registration Number	Establishment Name	Location
3042245424	Sino Protection Holding Co Limited Egypt Branch Ismailia Free Zone	Ismailia Al Isma'iliyah, EG
3016678045	Schneider ASR B.V.	Rotterdam-Albrandswaard Zuid-Holland, NL
8030672	Cirpro de Delicias S. de R.L. de C.V.	DELICIAS Chihuahua, MX
1527607	SRI Healthcare, LLC	MASON, OH, US
3027977504	MEDLINE CHILE SPA	Pudahuel Region Metropolitana, CL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680646. Last updated year: 2026. Please use registration number 9680646 when referencing this establishment in official correspondence.