K232784
- 510(k) number
- K232784
- Device name
- RELiZORB®
- Applicant
- Alcresta Therapeutics, Inc. MA · US
- Product code
- PLQ — Enzyme Packed Cartridge
- Decision date
- 2023-12-21
- Date received
- 2023-09-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K232784.pdf
Official FDA record: K232784
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.