MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE— 510(k) K092739

Name: FDA 510(k) clearance K092739
Creator: U.S. Food and Drug Administration
Published: 2010-01-12

Substantially Equivalent

C-Link Micro Imaging, Inc.

FDA 510(k) clearance K092739 for MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE, Substantially Equivalent on 2010-01-12. Applicant: C-Link Micro Imaging, Inc.. Device class: 2.

Clearance details

Applicant: C-Link Micro Imaging, Inc.
Product code: Code ODF
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2009-09-08
Decision date: 2010-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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