510(k) K041648
K041648 is an FDA 510(k) premarket notification submitted by Taewoong Medical Co., Ltd. for the device "NITI-S STENT & INTRODUCER, MODEL EOXXXX". The FDA issued a decision of Substantially Equivalent on April 28, 2005. The device falls under product code ESW (Prosthesis, Esophageal), a Class II device regulated under 21 CFR 878.3610. Taewoong Medical Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2005
- Date Received
- June 17, 2004
- 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