Data / Medical devices / United States / Soleva Pharma LLC
Soleva Pharma LLC: FDA-registered device maker in Robbinsville, NJ, United States, 2 510(k) clearances
Soleva Pharma LLC is registered with the FDA (registration 3016611551) in Robbinsville, NJ, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 16, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016611551
- Address
- 14 Main Street, Robbinsville, NJ, United States, 08691
- Owner or operator
- Soleva Pharma LLC (10062744)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- March 5, 2020
- Registered through
- 2026
- Brand names listed
- MuGard, ProctiGard
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oral Wound Dressing | OLR | U | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Protective Coating, Mucoadhesive Application, For The Rectal Mucosa | PHN | U | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 16, 2014 | K140558 | PROCTIGARD | PHN | Substantially Equivalent | Access Pharmaceuticals, Inc. | accessdata.fda.gov |
| December 11, 2006 | K062795 | MUGARD MUCOADHESIVE ORAL WOUND RINSE | OLR | Substantially Equivalent | Access Pharmaceuticals, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
- All makers of Oral Wound Dressing
Updated July 16, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.