Comfeel Seasorb Dressing
FDA 510(k) K983519 · Coloplast Corp.
510(k) numberK983519
Submission
- Device name
- Comfeel Seasorb Dressing
- Applicant
- Coloplast Corp.
Marietta, GA, US - Received
- October 8, 1998
- Decision date
- December 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KMF – Bandage, Liquid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5090
- Specialty
- General Hospital
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Questions and answers
When was Comfeel Seasorb Dressing cleared by the FDA?
Comfeel Seasorb Dressing (K983519) received a 510(k) decision of Substantially Equivalent on December 30, 1998, 83 days after the submission was received.
What is the product code of K983519?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.