FORMULATED SOLUTIONS, LLC

FDA Device Registration & Listing · Largo, FL, US · Registration 3005779557

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005779557
FEI Number
3005779557
Entity Name
FORMULATED SOLUTIONS, LLC
City/State/Country
Largo, FL, US
Establishment Address
11775 Starkey Road, Largo, FL 33773, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Formulated Solutions, LLC (Owner Number: 10033613)
Owner / Operator Contact Address
11775 Starkey Road, Largo, FL 33773, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Kelocote KELO-COTE; ScarAway Silicone Scar Gel KELO-COTE SPRAY

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MDA Elastomer, Silicone, For Scar Management General, Plastic Surgery Class 1 878.4025 2010-09-07
MDA Elastomer, Silicone, For Scar Management General, Plastic Surgery Class 1 878.4025 2014-06-03
MDA Elastomer, Silicone, For Scar Management General, Plastic Surgery Class 1 878.4025 2014-06-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Formulated Solutions, 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 3005779557. Last updated year: 2026. Please use registration number 3005779557 when referencing this establishment in official correspondence.
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