510(k) K150256
K150256 is an FDA 510(k) premarket notification submitted by Argentum Medical for the device "SILVERLON BURN CONTACT DRESSINGS". The FDA issued a decision of Substantially Equivalent on April 30, 2015. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Argentum Medical has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2015
- Date Received
- February 3, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type