510(k) K940396
K940396 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)". The FDA issued a decision of Substantially Equivalent on Oct 3, 1994. The device falls under product code ESW (Prosthesis, Esophageal), a Class II device regulated under 21 CFR 878.3610. Boston Scientific Scimed, Inc. has 34 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 3, 1994
- Date Received
- Jan 27, 1994
- 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
- 510(k)