Suprasorb A + Ag R
FDA 510(k) K183208 · Speciality Fibres and Materials, Ltd.
510(k) numberK183208
Submission
- Device name
- Suprasorb A + Ag R
- Applicant
- Speciality Fibres and Materials, Ltd.
Coventry, GB - Received
- November 19, 2018
- Decision date
- August 15, 2019
- 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 Suprasorb A + Ag R cleared by the FDA?
Suprasorb A + Ag R (K183208) received a 510(k) decision of Substantially Equivalent on August 15, 2019, 269 days after the submission was received.
What is the product code of K183208?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.