FDA Registration
Active
🇺🇸 United States
SMART CHOICE MEDICAL INC.
Reg #: 3012243264
·
FEI: 3012243264
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- SMART CHOICE MEDICAL INC.
- Registration Number
- 3012243264
- FEI Number
- 3012243264
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 15823 Monte St, Unit E105
- City
- Sylmar
- State
- CA
- ZIP
- 91342
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173123
Owner / Operator
- Firm Name
- Smart Choice Medical Inc
- Operator Number
- 10051227
- Address
- 15823 Monte St, Unit E105
- City
- Sylmar
- State
- CA
- Postal Code
- 91342
- Country
- US
- Correspondent
- Grikor Kavoukjian
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-03-25 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2016-02-19 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2017-01-25 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-21 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2020-04-21 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2018-06-16 |
Proprietary Names
Respirator, surgical
GARMENT, PROTECTIVE, FOR INCONTINENCE
BEDDING, DISPOSABLE, MEDICAL
ACCESSORY, SURGICAL APPAREL
Oximeter
COVER, MATTRESS (MEDICAL PURPOSES)
Establishment Types
Repack or Relabel Medical Device