510(k) K895696

ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PU by Delmed, Inc. — Product Code KNT

K895696 is an FDA 510(k) premarket notification submitted by Delmed, Inc. for the device "ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PU". The FDA issued a decision of Substantially Equivalent on May 2, 1990. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Delmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1990
Date Received
September 21, 1989
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