510(k) K841945

ENTERAL FEEDING BOTTLE by Superior Plastic Products Corp. — Product Code KNT

K841945 is an FDA 510(k) premarket notification submitted by Superior Plastic Products Corp. for the device "ENTERAL FEEDING BOTTLE". The FDA issued a decision of Substantially Equivalent on July 26, 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
July 26, 1984
Date Received
May 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