510(k) K072756

NON-IV ADAPTER FOR INFANT NG TUBE by Promedic, Inc. — Product Code KNT

K072756 is an FDA 510(k) premarket notification submitted by Promedic, Inc. for the device "NON-IV ADAPTER FOR INFANT NG TUBE". The FDA issued a decision of Substantially Equivalent (kit) on December 19, 2007. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Promedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 19, 2007
Date Received
September 27, 2007
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