US SPECIALTY FORMULATIONS

FDA Device Registration & Listing · Allentown, PA, US · Registration 3010680515

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010680515
FEI Number
3010680515
Entity Name
US SPECIALTY FORMULATIONS
City/State/Country
Allentown, PA, US
Establishment Address
1401 S Albert St, Allentown, PA 18103, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
US SPECIALTY FORMULATIONS (Owner Number: 10084330)
Owner / Operator Contact Address
1401 S Albert St, Allentown, PA 18103, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SPS-1

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2026-01-12
KDL Set, Perfusion, Kidney, Disposable Gastroenterology, Urology Class 2 876.5880 2022-02-10

Official Correspondent

KYLE FLANIGAN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

US SPECIALTY FORMULATIONS
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
K013575 Organ Recovery Systems, Inc. KPS-I, THE KIDNEY PERFUSION SOLUTION 2002-01-25

Similar Registrations

Registration Number Establishment Name Location
3027669473 TRAFEROX TECHNOLOGIES INC. Mississauga Ontario, CA
3031600052 OEM DEVELOPMENT SAINT BARTHELEMY D ANJOU Maine-et-Loire, FR
3007685782 S.A.L.F. LABORATORIO FRAMACOLOGICO Cenate Scotto Bergamo, IT
3024820181 INSTITUT GEORGES LOPEZ ST LAURENT DE CHAMOUSSET Rhone, FR
1067143 BIOCURE SOLUTIONS, LLC DBA BIOCURE, INC. Peachtree Corners, GA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010680515. Last updated year: 2026. Please use registration number 3010680515 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.