510(k) K093537
K093537 is an FDA 510(k) premarket notification submitted by M.I.Tech Co., Ltd. for the device "HANAROSTENT ESOPHAGUS (CCC)". The FDA issued a decision of Substantially Equivalent on June 4, 2010. 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
- June 4, 2010
- Date Received
- November 16, 2009
- Clearance Type
- Special
- 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