510(k) K973409

KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS by Davis & Geck, Inc. — Product Code KNT

K973409 is an FDA 510(k) premarket notification submitted by Davis & Geck, Inc. for the device "KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS". The FDA issued a decision of Substantially Equivalent on February 27, 1998. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Davis & Geck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1998
Date Received
September 9, 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