510(k) K871003

ENTROSET-SW by White River (Tm) — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1987
Date Received
March 12, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type