NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8— 510(k) K003489

Name: FDA 510(k) clearance K003489
Creator: U.S. Food and Drug Administration
Published: 2001-02-02

Substantially Equivalent

Medical Illumination International, Inc.

FDA 510(k) clearance K003489 for NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8, Substantially Equivalent on 2001-02-02. Applicant: Medical Illumination International, Inc.. Device class: 2.

Clearance details

Applicant: Medical Illumination International, Inc.
Product code: Code FSS
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2000-11-13
Decision date: 2001-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Fernando, CA, US

Download summary PDF View on FDA.gov ↗

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