510(k) K984628

MODIFICATION OF MOSS P.E.G. TRAY by Moss Tubes, Inc. — Product Code KNT

K984628 is an FDA 510(k) premarket notification submitted by Moss Tubes, Inc. for the device "MODIFICATION OF MOSS P.E.G. TRAY". The FDA issued a decision of Substantially Equivalent on March 17, 1999. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Moss Tubes, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1999
Date Received
December 30, 1998
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