510(k) K960632

KANGAROO FEEDING TUBE PLACMENT STYLET by Sherwood Medical Co. — Product Code KNT

K960632 is an FDA 510(k) premarket notification submitted by Sherwood Medical Co. for the device "KANGAROO FEEDING TUBE PLACMENT STYLET". The FDA issued a decision of Substantially Equivalent on May 9, 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 9, 1996
Date Received
February 14, 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