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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 K940046
Device Name NON-LUBRICATED CONDOM
Applicant
ANSELL, INC.
INDUSTRIAL RD.
POST OFFICE BOX 1252
DOTHAN,  AL  36302
Applicant Contact JOHN MOUSHALL
Correspondent
ANSELL, INC.
INDUSTRIAL RD.
POST OFFICE BOX 1252
DOTHAN,  AL  36302
Correspondent Contact JOHN MOUSHALL
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/05/1994
Decision Date 01/30/1995
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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