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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name douche apparatus, vaginal, therapeutic
510(k) Number K841710
Device Name MAC LEE VAGINAL IRRIGATOR
Applicant
MAC LEE MEDICAL PRODUCTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MAC LEE MEDICAL PRODUCTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.5900
Classification Product Code
HED  
Date Received04/24/1984
Decision Date 06/19/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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