GLOBAL HEALTHCARE VAGINAL SPECULUM— 510(k) K013835

Name: FDA 510(k) clearance K013835
Creator: U.S. Food and Drug Administration
Published: 2002-01-17

Substantially Equivalent

Dynascend Consulting Int'L, LLC

FDA 510(k) clearance K013835 for GLOBAL HEALTHCARE VAGINAL SPECULUM, Substantially Equivalent on 2002-01-17. Applicant: Dynascend Consulting Int'L, LLC. Device class: 2.

Clearance details

Applicant: Dynascend Consulting Int'L, LLC
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2001-11-19
Decision date: 2002-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

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