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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 K882389
Device Name KISS OF MINT(TM) NON-LUBRICATED CONDOM
Applicant
ANSELL, INC.
INDUSTRIAL RD.
POST OFFICE BOX 1252
DOTHAN,  AL  36302
Applicant Contact MICHAEL ENGLERT
Correspondent
ANSELL, INC.
INDUSTRIAL RD.
POST OFFICE BOX 1252
DOTHAN,  AL  36302
Correspondent Contact MICHAEL ENGLERT
Regulation Number884.5300
Classification Product Code
HIS  
Date Received06/10/1988
Decision Date 10/20/1988
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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