510(k) DEN150001
DEN150001 is an FDA 510(k) premarket notification submitted by Alcresta, Inc. for the device "RELIZORB". The FDA issued a decision of De Novo Granted on November 20, 2015. The device falls under product code PLQ (Enzyme Packed Cartridge), a Class II device regulated under 21 CFR 876.5985.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 20, 2015
- Date Received
- January 2, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Packed Cartridge
- Device Class
- Class II
- Regulation Number
- 876.5985
- Review Panel
- GU
- Submission Type
Hydrolyze fats in enteral formula.