510(k) K895824

L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET by Intl. Medical Marketing, Inc. — Product Code FPD

K895824 is an FDA 510(k) premarket notification submitted by Intl. Medical Marketing, Inc. for the device "L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET". 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. Intl. Medical Marketing, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1990
Date Received
September 29, 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