510(k) K885339

FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT by Superior Healthcare Group, Inc. — Product Code KNT

K885339 is an FDA 510(k) premarket notification submitted by Superior Healthcare Group, Inc. for the device "FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT". The FDA issued a decision of Substantially Equivalent on March 1, 1989. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Superior Healthcare Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1989
Date Received
December 28, 1988
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