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Found 2 results

510(k) Data Aggregation

K Number

Device Name

KELO-COTE SPRAY

Manufacturer

ADVANCED BIO-TECHNOLOGIES, INC.

Date Cleared

2006-04-14

(121 days)

Product Code

MDA

Regulation Number

878.4025

Why did this record match?

Applicant Name (Manufacturer) :

ADVANCED BIO-TECHNOLOGIES, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Kelo-Cote Spray is a topical silicone spray intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Device Description

Kelo-Cote Spray is a lightweight, self-drying silicone gel spray for the treatment of scars. Upon drying, the silicone gel layer forms a film for the management of scars. The components of Kelo-Cote Spray include fumed silica and silicone elastomer, liquid, and gum. It is provided in a can with a spray nozzle for application purposes.

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K Number

Device Name

KELO-COTE TOPICAL GEL

Manufacturer

ADVANCED BIO-TECHNOLOGIES, INC.

Date Cleared

2001-01-05

(144 days)

Product Code

MDA

Regulation Number

878.4025

Why did this record match?

Applicant Name (Manufacturer) :

ADVANCED BIO-TECHNOLOGIES, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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