Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2518423

FEI Number

2518423

Entity Name

BERKLEY MEDICAL RESOURCES, INC.

City/State/Country

Smithfield, PA, US

Establishment Address

700 Mountain View Dr, Smithfield, PA 15478, US

Establishment Type(s)

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

Owner / Operator

BERKLEY MEDICAL RESOURCES, INC. (Owner Number: 2518423)

Owner / Operator Contact Address

700 Mountainview Drive, --, Smithfield, PA 15478, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K922716

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
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2014-10-17

Official Correspondent

Domenic Tommarello

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BERKLEY MEDICAL RESOURCES, INC.

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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09

Similar Registrations

Registration Number	Establishment Name	Location
3016247944	HYGENIX HEALTH SOLUTIONS LLC	Torrance, CA, US
3016765490	XIAMEN CHUANFUTANG PHARMACEUTICAL CO.,LTD	xiamen Fujian, CN
3018382937	MID-AMERICA SAFETY CORP	Elk Grove Village, IL, US
3017598017	DURIO PPE SDN. BHD.	Johor Bahru, MY
3002813051	IRIS USA INC	Pleasant Prairie, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2518423. Last updated year: 2026. Please use registration number 2518423 when referencing this establishment in official correspondence.