DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE— 510(k) K052314

Name: FDA 510(k) clearance K052314
Creator: U.S. Food and Drug Administration
Published: 2005-11-09

Substantially Equivalent

Dynarex Corp.

FDA 510(k) clearance K052314 for DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE, Substantially Equivalent on 2005-11-09. Applicant: Dynarex Corp.. Device class: 2.

Clearance details

Applicant: Dynarex Corp.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2005-08-25
Decision date: 2005-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, US

Download summary PDF View on FDA.gov ↗

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