510(k) K020318
K020318 is an FDA 510(k) premarket notification submitted by Scivolutions, Inc. for the device "SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES". The FDA issued a decision of Substantially Equivalent on February 3, 2003. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Scivolutions, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 2003
- Date Received
- January 30, 2002
- 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