510(k) K853253

CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI by Corpak Co. — Product Code KNT

K853253 is an FDA 510(k) premarket notification submitted by Corpak Co. for the device "CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI". The FDA issued a decision of Substantially Equivalent on November 5, 1985. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Corpak Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1985
Date Received
August 2, 1985
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