MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)— 510(k) K081698

Name: FDA 510(k) clearance K081698
Creator: U.S. Food and Drug Administration
Published: 2008-07-30

Substantially Equivalent

Image Stream Medical, Inc.

FDA 510(k) clearance K081698 for MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC), Substantially Equivalent on 2008-07-30. Applicant: Image Stream Medical, Inc.. Device class: 2.

Clearance details

Applicant: Image Stream Medical, Inc.
Product code: Code FTA
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2008-06-17
Decision date: 2008-07-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Winchester, MA, US

Download summary PDF View on FDA.gov ↗

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