510(k) K896559

INFANT FEEDING TUBE by Westmark, Sterile Packing Systems, Inc. (Sps) — Product Code FPD

K896559 is an FDA 510(k) premarket notification submitted by Westmark, Sterile Packing Systems, Inc. (Sps) for the device "INFANT FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on March 13, 1990. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Westmark, Sterile Packing Systems, Inc. (Sps) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1990
Date Received
November 17, 1989
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