510(k) K960677

KANGAROO JEJUNAL FEEDING SYSTEM by Sherwood Medical Co. — Product Code KNT

K960677 is an FDA 510(k) premarket notification submitted by Sherwood Medical Co. for the device "KANGAROO JEJUNAL FEEDING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 13, 1996. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Sherwood Medical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1996
Date Received
February 16, 1996
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