510(k) K970178

CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM by Corpak, Inc. — Product Code KNT

K970178 is an FDA 510(k) premarket notification submitted by Corpak, Inc. for the device "CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 21, 1997. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Corpak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1997
Date Received
January 17, 1997
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