510(k) K070457
K070457 is an FDA 510(k) premarket notification submitted by Sun Scientific, LLC for the device "SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB". The FDA issued a decision of Substantially Equivalent on May 16, 2007. The device falls under product code MHW (Dressing, Compression), a Class I device regulated under 21 CFR 880.5075. Sun Scientific, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2007
- Date Received
- Feb 16, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Compression
- Device Class
- Class I
- Regulation Number
- 880.5075
- Review Panel
- SU
- Submission Type