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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 K864400
Device Name EXTRA STRONG CONDOM
Applicant
ANSELL, INC.
INDUSTRIAL RD.
POST OFFICE BOX 1252
DOTHAN,  AL  36302
Applicant Contact BRADLEY PUGH
Correspondent
ANSELL, INC.
INDUSTRIAL RD.
POST OFFICE BOX 1252
DOTHAN,  AL  36302
Correspondent Contact BRADLEY PUGH
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/06/1986
Decision Date 02/02/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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