MAC LEE VAGINAL IRRIGATOR— 510(k) K841710

Name: FDA 510(k) clearance K841710
Creator: U.S. Food and Drug Administration
Published: 1984-06-19

Substantially Equivalent

Mac Lee Medical Products

FDA 510(k) clearance K841710 for MAC LEE VAGINAL IRRIGATOR, Substantially Equivalent on 1984-06-19. Applicant: Mac Lee Medical Products. Device class: 1.

Clearance details

Applicant: Mac Lee Medical Products
Product code: Code HED
Device class: Class 1
Regulation: 21 CFR 884.5900
Advisory panel: Obstetrics/Gynecology
Date received: 1984-04-24
Decision date: 1984-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.