510(k) K984208
K984208 is an FDA 510(k) premarket notification submitted by Argentum International, LLC for the device "SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD". The FDA issued a decision of Substantially Equivalent on February 22, 1999. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Argentum International, LLC has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 1999
- Date Received
- November 24, 1998
- 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