RELiZORB (100300/ 100301)— 510(k) K243284
Substantially EquivalentAlcresta Therapeutics, Inc.
FDA 510(k) clearance K243284 for RELiZORB (100300/ 100301), Substantially Equivalent on 2025-01-15. Applicant: Alcresta Therapeutics, Inc.. Device class: 2.
Clearance details
- Applicant
- Alcresta Therapeutics, Inc.
- Product code
- Code PLQ
- Device class
- Class 2
- Regulation
- 21 CFR 876.5985
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
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