Alcyone MEMS Cannula (AMC) System— 510(k) K150660

Name: FDA 510(k) clearance K150660
Creator: U.S. Food and Drug Administration
Published: 2015-04-16

Substantially Equivalent

Alcyone Lifesciences, Inc.

FDA 510(k) clearance K150660 for Alcyone MEMS Cannula (AMC) System, Substantially Equivalent on 2015-04-16. Applicant: Alcyone Lifesciences, Inc.. Device class: 1.

Clearance details

Applicant: Alcyone Lifesciences, Inc.
Product code: Code HCD
Device class: Class 1
Regulation: 21 CFR 882.4060
Advisory panel: Neurology
Date received: 2015-03-13
Decision date: 2015-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lowell, MA, US

Download summary PDF View on FDA.gov ↗

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