EASYSUITE SURGICAL LIGHT CONTROL (ESLC)— 510(k) K102791

Name: FDA 510(k) clearance K102791
Creator: U.S. Food and Drug Administration
Published: 2010-11-23

Substantially Equivalent

Image Stream Medical, Inc.

FDA 510(k) clearance K102791 for EASYSUITE SURGICAL LIGHT CONTROL (ESLC), Substantially Equivalent on 2010-11-23. 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: 2010-09-27
Decision date: 2010-11-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Littleton, MA, US

Download summary PDF View on FDA.gov ↗

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