510(k) K872097

INFANT FEEDING TUBE by Tri-State Hospital Supply Corp. — Product Code KNT

K872097 is an FDA 510(k) premarket notification submitted by Tri-State Hospital Supply Corp. for the device "INFANT FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on August 25, 1987. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Tri-State Hospital Supply Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1987
Date Received
June 1, 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