Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016611551

FEI Number

3016611551

Entity Name

SOLEVA PHARMA LLC

City/State/Country

Robbinsville, NJ, US

Establishment Address

14 Main Street, Robbinsville, NJ 08691, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Soleva Pharma LLC (Owner Number: 10062744)

Owner / Operator Contact Address

14 Main Street, Robbinsville, NJ 08691, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140558

PMA Number

N/A

All Registered Proprietary Names

MuGard ProctiGard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2020-03-05
PHN	Protective Coating, Mucoadhesive Application, For The Rectal Mucosa	Unknown	Class U	N/A	2020-03-05

Official Correspondent

Andrew Aromando

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Soleva Pharma LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016611551. Last updated year: 2026. Please use registration number 3016611551 when referencing this establishment in official correspondence.