510(k) K831328

NEONATAL NASOGASTRIC FEEDING TUBE- by Corpak Medsystems — Product Code KNT

K831328 is an FDA 510(k) premarket notification submitted by Corpak Medsystems for the device "NEONATAL NASOGASTRIC FEEDING TUBE-". The FDA issued a decision of Substantially Equivalent on July 19, 1983. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Corpak Medsystems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1983
Date Received
April 25, 1983
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