510(k) K070836
K070836 is an FDA 510(k) premarket notification submitted by Clevex, Inc. for the device "EXICLIP EXCS-M". The FDA issued a decision of Substantially Equivalent on April 20, 2007. The device falls under product code MJG (Device, Percutaneous, Biopsy), a Class I device regulated under 21 CFR 878.4800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2007
- Date Received
- March 27, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Percutaneous, Biopsy
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type