510(k) K895330

600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA by Delmed, Inc. — Product Code KNT

K895330 is an FDA 510(k) premarket notification submitted by Delmed, Inc. for the device "600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA". 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
August 31, 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