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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 K010371
Device Name LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT
Applicant
SURETEX, LTD.
1500 INDUSTRIAL RD.
P.O. BOX 1252
DOTHAN,  AL  36302
Applicant Contact LON D MCILVAIN
Correspondent
SURETEX, LTD.
1500 INDUSTRIAL RD.
P.O. BOX 1252
DOTHAN,  AL  36302
Correspondent Contact LON D MCILVAIN
Regulation Number884.5300
Classification Product Code
HIS  
Subsequent Product Code
LTZ  
Date Received02/07/2001
Decision Date 04/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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