510(k) K896390
K896390 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "WILSON-COOK ESOPHAGEAL PROSTHESIS". The FDA issued a decision of Substantially Equivalent on December 27, 1989. The device falls under product code JCQ (Prosthesis, Esophagus), a Class II device regulated under 21 CFR 878.3610. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 1989
- Date Received
- November 6, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Esophagus
- Device Class
- Class II
- Regulation Number
- 878.3610
- Review Panel
- SU
- Submission Type