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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 K984392
Device Name ANSELL CONDOMS
Applicant
ANSELL, INC.
1500 INDUSTRIAL RD.
dothan,  AL  36303
Applicant Contact lon mcllvain
Correspondent
ANSELL, INC.
1500 INDUSTRIAL RD.
dothan,  AL  36303
Correspondent Contact lon mcllvain
Regulation Number884.5300
Classification Product Code
HIS  
Subsequent Product Code
LTZ  
Date Received12/08/1998
Decision Date 07/21/1999
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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