510(k) K821906

CORPAK ENTERIC FEEDING TUBE W/GUIDE TIP by Corpak Medsystems — Product Code KNT

K821906 is an FDA 510(k) premarket notification submitted by Corpak Medsystems for the device "CORPAK ENTERIC FEEDING TUBE W/GUIDE TIP". The FDA issued a decision of Substantially Equivalent on July 13, 1982. 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 13, 1982
Date Received
June 28, 1982
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