Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014258951

FEI Number

3014258951

Entity Name

Premier Brands of America Inc.

City/State/Country

Hudson, NY, US

Establishment Address

351 Fairview Ave, Hudson, NY 12534, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

PREMIER BRANDS OF AMERICA INC. (Owner Number: 2434554)

Owner / Operator Contact Address

170 Hamilton Avenue, Suite 201, White Plains, NY 10601, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K090848

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	1988-09-22
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2013-11-04
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2012-06-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-06-21

Official Correspondent

Elizabeth Castro

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PREMIER BRANDS OF AMERICA 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
3017048841	PREMIER BRANDS OF AMERICA INC.	Orangeburg, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

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3038624835	DONGGUAN HEECOOL TECHNOLOGY CO., LTD.	Dongguan Guangdong, CN
3010364377	Flexor SA	Barbera del Valles Barcelona, ES
3016232365	SHENZHEN FOAMTECH CO., LTD	Shenzhen Guangdong, CN
2184046	OSBORN MEDICAL CORPORATION	CENTENNIAL, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014258951. Last updated year: 2026. Please use registration number 3014258951 when referencing this establishment in official correspondence.