Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin Silicone Scar Therapy Gel, Model 09916030.
FDA 510(k) K014036 · Medtrade Products , Ltd.
510(k) numberK014036
Submission
- Device name
- Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin Silicone Scar Therapy Gel, Model 09916030.
- Applicant
- Medtrade Products , Ltd.
Crewe, GB - Received
- December 7, 2001
- Decision date
- February 14, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K024057 | Curad Scar TherapyMDA · Traditional | Beiersdorf, Inc. | 06/18/2003SE |
| K024160 | Neosporin Scar SolutionMDA · Traditional | Warner-Lambert Co. | 03/17/2003SE |
| K023678 | Dimisil Scar GelMDA · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 01/23/2003SE |
| K023136 | Oleeva FabricMDA · Special | Bio Med Sciences, Inc. | 10/16/2002SE |
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Questions and answers
When was Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin Silicone Scar Therapy Gel, Model 09916030. cleared by the FDA?
Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin Silicone Scar Therapy Gel, Model 09916030. (K014036) received a 510(k) decision of Substantially Equivalent on February 14, 2002, 69 days after the submission was received.
What is the product code of K014036?
The FDA product code is MDA – Elastomer, Silicone, For Scar Management, a Class I (low risk) device regulated under 21 CFR 878.4025.