510(k) K090584
K090584 is an FDA 510(k) premarket notification submitted by Carl Zeiss Surgical GmbH for the device "INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS". The FDA issued a decision of Substantially Equivalent on November 24, 2009. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Carl Zeiss Surgical GmbH has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 2009
- Date Received
- March 3, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Therapeutic, X-Ray
- Device Class
- Class II
- Regulation Number
- 892.5900
- Review Panel
- RA
- Submission Type