FDA Registration
Active
🇺🇸 United States
DELTA HI-TECH, INC.
Reg #: 1721183
·
FEI: 3001239292
·
Expires 2026
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- DELTA HI-TECH, INC.
- Registration Number
- 1721183
- FEI Number
- 3001239292
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 8695 Seward Road
- City
- Fairfield
- State
- OH
- ZIP
- 45011
- Country
- US
Regulatory Submissions
- 510(k) Number
- K102178
Owner / Operator
- Firm Name
- DELTA HI-TECH, INC.
- Operator Number
- 1721183
- Address
- 8695 Seward Road, --
- City
- Fairfield
- State
- OH
- Postal Code
- 45011
- Country
- US
- Correspondent
- Richard T Lauer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2018-09-12 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2015-08-31 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2015-08-31 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2015-08-31 |
Proprietary Names
Aimsco Lancet
Establishment Types
Complaint File Establishment per 21 CFR 820.198