FDA Registration
Active
🇺🇸 United States
ASAP OTC Wound Dressing Gel
Reg #: 3008396914
·
FEI: 3008396914
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABL Manufacturing, LLC
- Registration Number
- 3008396914
- FEI Number
- 3008396914
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1306 South 630 East
- City
- American Fork
- State
- UT
- ZIP
- 84003
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140483
Owner / Operator
- Firm Name
- ABL Manufacturing, LLC
- Operator Number
- 10033426
- Address
- ABL Manufacturing, LLC, 1306 south 630 east
- City
- Am Fork
- State
- UT
- Postal Code
- 84003
- Country
- US
- Correspondent
- Nathan Moeller
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2014-08-06 |
Proprietary Names
ASAP OTC Wound Dressing Gel
Armor Gel Wound Dressing Gel
Q Restore Wound Dressing Gel
Rescue Wound Dressing Gel
Silvex Wound Dressing Gel
A AfterCare Wound Dressing Gel
Dahryn Wound Dressing Gel
OTC 24 Wound Dressing Gel
Super Silver Wound Dressing Gel
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)