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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 K000408
Device Name LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM
Applicant
SURETEX PROPHYLACTICS LTD.
1500 INDUSTRIAL RD.
P.O. 1252
DOTHAN,  AL  36302
Applicant Contact LON D MCINVAIN
Correspondent
SURETEX PROPHYLACTICS LTD.
1500 INDUSTRIAL RD.
P.O. 1252
DOTHAN,  AL  36302
Correspondent Contact LON D MCINVAIN
Regulation Number884.5300
Classification Product Code
HIS  
Date Received02/08/2000
Decision Date 04/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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