510(k) K896390

WILSON-COOK ESOPHAGEAL PROSTHESIS by Wilson-Cook Medical, Inc. — Product Code JCQ

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