FEMSPEC DISPOSABLE VAGINAL SPECULUM— 510(k) K041757

Name: FDA 510(k) clearance K041757
Creator: U.S. Food and Drug Administration
Published: 2004-12-23

Substantially Equivalent

Femspec LLC

FDA 510(k) clearance K041757 for FEMSPEC DISPOSABLE VAGINAL SPECULUM, Substantially Equivalent on 2004-12-23. Applicant: Femspec LLC. Device class: 2.

Clearance details

Applicant: Femspec LLC
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2004-06-29
Decision date: 2004-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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