LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM— 510(k) K021012

Name: FDA 510(k) clearance K021012
Creator: U.S. Food and Drug Administration
Published: 2002-06-25

Substantially Equivalent

Quality Medical Solusions, LLC

FDA 510(k) clearance K021012 for LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM, Substantially Equivalent on 2002-06-25. Applicant: Quality Medical Solusions, LLC. Device class: 2.

Clearance details

Applicant: Quality Medical Solusions, LLC
Product code: Code HDY
Device class: Class 2
Regulation: 21 CFR 884.4260
Advisory panel: Obstetrics/Gynecology
Date received: 2002-03-29
Decision date: 2002-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

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