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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
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