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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 K030176
Device Name LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT
Applicant
Suretex, Ltd.
1500 Industrial Rd.
P.O. Box 1252
Dothan,  AL  36302
Applicant Contact CYNTHIA A INGRAM
Correspondent
Suretex, Ltd.
1500 Industrial Rd.
P.O. Box 1252
Dothan,  AL  36302
Correspondent Contact CYNTHIA A INGRAM
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/17/2003
Decision Date 04/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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