510(k) K072094
K072094 is an FDA 510(k) premarket notification submitted by M.I.Tech Co., Ltd. for the device "CHOOSTENT". The FDA issued a decision of Substantially Equivalent on September 25, 2008. The device falls under product code ESW (Prosthesis, Esophageal), a Class II device regulated under 21 CFR 878.3610. M.I.Tech Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 2008
- Date Received
- July 30, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Esophageal
- Device Class
- Class II
- Regulation Number
- 878.3610
- Review Panel
- GU
- Submission Type