AQUACEL Ag Surgical SP Dressing
FDA 510(k) K152926 · Convatec Limited
510(k) numberK152926
Submission
- Device name
- AQUACEL Ag Surgical SP Dressing
- Applicant
- Convatec Limited
Deeside, GB - Received
- October 5, 2015
- Decision date
- January 21, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 AQUACEL Ag Surgical SP Dressing cleared by the FDA?
AQUACEL Ag Surgical SP Dressing (K152926) received a 510(k) decision of Substantially Equivalent on January 21, 2016, 108 days after the submission was received.
What is the product code of K152926?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.