510(k) K843975

9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE by Superior Plastic Products Corp. — Product Code KNT

K843975 is an FDA 510(k) premarket notification submitted by Superior Plastic Products Corp. for the device "9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE". The FDA issued a decision of Substantially Equivalent on November 20, 1984. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Superior Plastic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1984
Date Received
October 11, 1984
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