510(k) K092758
K092758 is an FDA 510(k) premarket notification submitted by Saeshin Precision Co., Ltd. for the device "X-CUBE". The FDA issued a decision of Substantially Equivalent on September 21, 2009. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. Saeshin Precision Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 2009
- Date Received
- September 9, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Controller, Foot, Handpiece And Cord
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type