Specialty Manufacturing, Inc.

FDA Device Registration & Listing · Saginaw, MI, US · Registration 1831948

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
1831948
FEI Number
1831948
Entity Name
Specialty Manufacturing, Inc.
City/State/Country
Saginaw, MI, US
Establishment Address
2210 Midland Road, Saginaw, MI 48603, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Specialty Manufacturing, Inc. (Owner Number: 10021842)
Owner / Operator Contact Address
2210 Midland Road, Saginaw, MI 48603, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
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
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2018-11-05

Official Correspondent

Kathleen Thompson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Specialty Manufacturing, 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
K832124 Med-West, Inc. CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI 1983-08-12
K162500 Spyder Medical Ostial Sprit Cannulae 2017-01-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2022 Medtronic Perfusion Systems 2
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018 OriGen Biomedical, Inc. 2
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1831948. Last updated year: 2026. Please use registration number 1831948 when referencing this establishment in official correspondence.
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