FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I— 510(k) K052192

Name: FDA 510(k) clearance K052192
Creator: U.S. Food and Drug Administration
Published: 2006-02-02

Substantially Equivalent

Femspec LLC

FDA 510(k) clearance K052192 for FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I, Substantially Equivalent on 2006-02-02. 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: 2005-08-11
Decision date: 2006-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Townsend, WA, US

Download summary PDF View on FDA.gov ↗

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