Servator P SALF Solution with THAM— 510(k) K202652

Name: FDA 510(k) clearance K202652
Creator: U.S. Food and Drug Administration
Published: 2021-08-19

Substantially Equivalent

S.A.L.F. Spa

FDA 510(k) clearance K202652 for Servator P SALF Solution with THAM, Substantially Equivalent on 2021-08-19. Applicant: S.A.L.F. Spa. Device class: 2.

Clearance details

Applicant: S.A.L.F. Spa
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2020-09-14
Decision date: 2021-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cenate Sotto, IT

Download summary PDF View on FDA.gov ↗

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K190063 — Servator C SALF Solution2019-08-14
K180481 — Servator B SALF Solution2018-06-29
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Data sourced from openFDA. This site is unofficial and independent of the FDA.