RELiZORB— 510(k) K191379
Substantially EquivalentAlcresta Therapeutics, Inc.
FDA 510(k) clearance K191379 for RELiZORB, Substantially Equivalent on 2019-12-04. 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
- Newton, MA, US
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