510(k) K954218

STERILE FEEDING TUBE by Baxter Healthcare Corp — Product Code FPD

K954218 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "STERILE FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on Nov 3, 1995. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 3, 1995
Date Received
Sep 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Tube, Feeding
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type
510(k)

Source: FDA 510(k) database entry for K954218. Report a data issue: hello@regdatalab.com.