Jobskin Continuing Care
FDA 510(k) K925583 · Jobst Institute, Inc.
510(k) numberK925583
Submission
- Device name
- Jobskin Continuing Care
- Applicant
- Jobst Institute, Inc.
Toledo, OH, US - Received
- November 5, 1992
- Decision date
- April 4, 1994
- 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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Questions and answers
When was Jobskin Continuing Care cleared by the FDA?
Jobskin Continuing Care (K925583) received a 510(k) decision of Substantially Equivalent on April 4, 1994, 515 days after the submission was received.
What is the product code of K925583?
The FDA product code is MDA – Elastomer, Silicone, For Scar Management, a Class I (low risk) device regulated under 21 CFR 878.4025.