510(k) K873119
K873119 is an FDA 510(k) premarket notification submitted by Frantz Medical Development, Ltd. for the device "FLEXIFLO COMPANION ENTERAL NUTRITION PUMP". The FDA issued a decision of Substantially Equivalent on November 5, 1987. The device falls under product code LZH (Pump, Infusion, Enteral), a Class II device regulated under 21 CFR 880.5725. Frantz Medical Development, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1987
- Date Received
- August 10, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Enteral
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type