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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 K033076
Device Name LIFESTYLES LIQUID PERSONAL LUBRICANT
Applicant
ANSELL HEALTHCARE, INC.
1635 INDUSTRIAL RD.
dothan,  AL  36303
Applicant Contact lon d mcilvain
Correspondent
ANSELL HEALTHCARE, INC.
1635 INDUSTRIAL RD.
dothan,  AL  36303
Correspondent Contact lon d mcilvain
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/29/2003
Decision Date 12/19/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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