K191379 is an FDA 510(k) clearance for the RELiZORB. This device is classified as a Enzyme Packed Cartridge (Class II - Special Controls, product code PLQ).
Submitted by Alcresta Therapeutics, Inc. (Newton, US). The FDA issued a Cleared decision on December 4, 2019, 195 days after receiving the submission on May 23, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5985. Hydrolyze Fats In Enteral Formula..
| 510(k) Number | K191379 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2019 |
| Decision Date | December 04, 2019 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PLQ - Enzyme Packed Cartridge |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5985 |
| Definition | Hydrolyze Fats In Enteral Formula. |