510(k) K895824
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