510(k) K191379
K191379 is an FDA 510(k) premarket notification submitted by Alcresta Therapeutics, Inc. for the device "RELiZORB". The FDA issued a decision of Substantially Equivalent on December 4, 2019. The device falls under product code PLQ (Enzyme Packed Cartridge), a Class II device regulated under 21 CFR 876.5985. Alcresta Therapeutics, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 2019
- Date Received
- May 23, 2019
- Clearance Type
- Traditional
- 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.