510(k) K081713
K081713 is an FDA 510(k) premarket notification submitted by Vidacare Corporation for the device "VERTEBRAL ACCESS SYSTEM BY VIDACARE". The FDA issued a decision of Substantially Equivalent on November 21, 2008. The device falls under product code MOQ (Battery, Replacement, Rechargeable), a Class I device regulated under 21 CFR 878.4820. Vidacare Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2008
- Date Received
- June 17, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Battery, Replacement, Rechargeable
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type