510(k) K895919

ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III by Delmed, Inc. — Product Code KNT

K895919 is an FDA 510(k) premarket notification submitted by Delmed, Inc. for the device "ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III". 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
October 10, 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