510(k) K173675
K173675 is an FDA 510(k) premarket notification submitted by Convatec Limited for the device "AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber". The FDA issued a decision of Substantially Equivalent on Jul 20, 2018. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Convatec Limited has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 20, 2018
- Date Received
- Nov 30, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)