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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 K120394
Device Name LIFESTYLES ZERO LUBRICATED LATEX CONDOM
Applicant
ANSELL HEATHCARE PRODUCTS LLC
1635 INDUSTRIAL ROAD
DOTHAN,  AL  36303
Applicant Contact CYNTHIA INGRAM
Correspondent
ANSELL HEATHCARE PRODUCTS LLC
1635 INDUSTRIAL ROAD
DOTHAN,  AL  36303
Correspondent Contact CYNTHIA INGRAM
Regulation Number884.5300
Classification Product Code
HIS  
Date Received02/08/2012
Decision Date 05/08/2012
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
Recalls CDRH Recalls
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