IGS VAGINAL SPECULUM— 510(k) K060129

Name: FDA 510(k) clearance K060129
Creator: U.S. Food and Drug Administration
Published: 2006-05-04

Substantially Equivalent

Innovative Gynecological Solutions, LLC

FDA 510(k) clearance K060129 for IGS VAGINAL SPECULUM, Substantially Equivalent on 2006-05-04. Applicant: Innovative Gynecological Solutions, LLC. Device class: 2.

Clearance details

Applicant: Innovative Gynecological Solutions, LLC
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2006-01-18
Decision date: 2006-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson, NH, US

Download summary PDF View on FDA.gov ↗

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