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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom, Synthetic
510(k) Number K070800
Device Name LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM
Applicant
Ansell Healthcare Products, LLC
1635 Industrial Rd.
Dothan,  AL  36303
Applicant Contact LON D MCILVAIN
Correspondent
Ansell Healthcare Products, LLC
1635 Industrial Rd.
Dothan,  AL  36303
Correspondent Contact LON D MCILVAIN
Regulation Number884.5300
Classification Product Code
MOL  
Date Received03/23/2007
Decision Date 03/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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