510(k) K070426
K070426 is an FDA 510(k) premarket notification submitted by Aranz Medical Limited for the device "SILHOUETTE, MODEL 1000.01". The FDA issued a decision of Substantially Equivalent on June 29, 2007. The device falls under product code FXN (Tape, Camera, Surgical), a Class I device regulated under 21 CFR 878.4160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2007
- Date Received
- February 13, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tape, Camera, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type