510(k) K821067

VIVONEX ACUTROL ENTERNAL FEEDING SYS by Norwich Eaton Pharmaceuticals, Inc. — Product Code KNT

K821067 is an FDA 510(k) premarket notification submitted by Norwich Eaton Pharmaceuticals, Inc. for the device "VIVONEX ACUTROL ENTERNAL FEEDING SYS". The FDA issued a decision of Substantially Equivalent on April 29, 1982. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Norwich Eaton Pharmaceuticals, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1982
Date Received
April 16, 1982
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