Sween Woun'Dres
FDA 510(k) K983042 · Coloplast Corp.
510(k) numberK983042
Submission
- Device name
- Sween Woun'Dres
- Applicant
- Coloplast Corp.
North Mankato, MN, US - Received
- August 31, 1998
- Decision date
- November 25, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- Device class
- Unclassified
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Questions and answers
When was Sween Woun'Dres cleared by the FDA?
Sween Woun'Dres (K983042) received a 510(k) decision of Substantially Equivalent on November 25, 1998, 86 days after the submission was received.
What is the product code of K983042?
The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.