Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1721183

FEI Number

3001239292

Entity Name

DELTA HI-TECH, INC.

City/State/Country

Fairfield, OH, US

Establishment Address

8695 Seward Road, Fairfield, OH 45011, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

DELTA HI-TECH, INC. (Owner Number: 1721183)

Owner / Operator Contact Address

8695 Seward Road, --, Fairfield, OH 45011, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K163578

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
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-09-12
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-08-31
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2015-08-31
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2015-08-31
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-12-17

Official Correspondent

Richard Lauer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DELTA HI-TECH, 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
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

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3021067373	VVT MED Ltd	Kfar Saba Central, IL
3009249481	JMS Co.,Ltd. Miyoshi Plant	Miyoshi Hiroshima, JP
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1721183. Last updated year: 2026. Please use registration number 1721183 when referencing this establishment in official correspondence.