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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 K001883
Device Name LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
Applicant
Ansell Healthcare, Inc.
1500 Industrial Rd.
P.O. Box 1252
Dothan,  AL  36302
Applicant Contact LON D MCILVAIN
Correspondent
Ansell Healthcare, Inc.
1500 Industrial Rd.
P.O. Box 1252
Dothan,  AL  36302
Correspondent Contact LON D MCILVAIN
Regulation Number884.5300
Classification Product Code
HIS  
Subsequent Product Code
LTZ  
Date Received06/21/2000
Decision Date 07/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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