510(k) K100288

NEOMED ENTERAL ONLY EXTENSION SET by Neomed, Inc. — Product Code KNT

K100288 is an FDA 510(k) premarket notification submitted by Neomed, Inc. for the device "NEOMED ENTERAL ONLY EXTENSION SET". The FDA issued a decision of Substantially Equivalent on August 3, 2010. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Neomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2010
Date Received
February 1, 2010
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