510(k) K830989

BAKER JEJUNOSTOMY TUBE by Medovations, Inc. — Product Code KNT

K830989 is an FDA 510(k) premarket notification submitted by Medovations, Inc. for the device "BAKER JEJUNOSTOMY TUBE". The FDA issued a decision of Substantially Equivalent on June 2, 1983. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Medovations, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1983
Date Received
March 29, 1983
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