Kelo-Cote Spray

FDA 510(k) K053481 · Advanced Bio-Technologies, Inc.

Substantially Equivalent

510(k) numberK053481

Submission

Device name
Kelo-Cote Spray
Applicant
Advanced Bio-Technologies, Inc.
Redmond, WA, US
Received
December 14, 2005
Decision date
April 14, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MDA – Elastomer, Silicone, For Scar Management
Device class
Class I (low risk)
Regulation
21 CFR 878.4025
Specialty
General, Plastic Surgery

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Questions and answers

When was Kelo-Cote Spray cleared by the FDA?

Kelo-Cote Spray (K053481) received a 510(k) decision of Substantially Equivalent on April 14, 2006, 121 days after the submission was received.

What is the product code of K053481?

The FDA product code is MDA – Elastomer, Silicone, For Scar Management, a Class I (low risk) device regulated under 21 CFR 878.4025.