CLEARSPEC SINGLE USE VAGINAL SPECULUM— 510(k) K130046

Name: FDA 510(k) clearance K130046
Creator: U.S. Food and Drug Administration
Published: 2013-08-06

Substantially Equivalent

Clearspec, LLC

FDA 510(k) clearance K130046 for CLEARSPEC SINGLE USE VAGINAL SPECULUM, Substantially Equivalent on 2013-08-06. Applicant: Clearspec, LLC. Device class: 2.

Clearance details

Applicant: Clearspec, LLC
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2013-01-08
Decision date: 2013-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herkimer, NY, US

Download summary PDF View on FDA.gov ↗

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