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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K822792
Device Name NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT
Applicant
ANSELL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ANSELL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/15/1982
Decision Date 09/30/1982
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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