510(k) K821231

VIVONEX TUNGSTEN TIP TUBE PLACEMENT by Norwich Eaton Pharmaceuticals, Inc. — Product Code KNT

K821231 is an FDA 510(k) premarket notification submitted by Norwich Eaton Pharmaceuticals, Inc. for the device "VIVONEX TUNGSTEN TIP TUBE PLACEMENT". The FDA issued a decision of Substantially Equivalent on May 10, 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
May 10, 1982
Date Received
April 27, 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