Contreet Foam Adhesive/Non-Adhesive
FDA 510(k) K022416 · Coloplast Corp.
510(k) numberK022416
Submission
- Device name
- Contreet Foam Adhesive/Non-Adhesive
- Applicant
- Coloplast Corp.
North Mankato, MN, US - Received
- July 24, 2002
- Decision date
- February 3, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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Questions and answers
When was Contreet Foam Adhesive/Non-Adhesive cleared by the FDA?
Contreet Foam Adhesive/Non-Adhesive (K022416) received a 510(k) decision of Substantially Equivalent on February 3, 2003, 194 days after the submission was received.
What is the product code of K022416?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.