G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM— 510(k) K052420

Name: FDA 510(k) clearance K052420
Creator: U.S. Food and Drug Administration
Published: 2006-04-06

Substantially Equivalent

Gynova, LLC

FDA 510(k) clearance K052420 for G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM, Substantially Equivalent on 2006-04-06. Applicant: Gynova, LLC. Device class: 2.

Clearance details

Applicant: Gynova, LLC
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2005-09-02
Decision date: 2006-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, CT, US

Download summary PDF View on FDA.gov ↗

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