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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 K060797
Device Name NAKED
Applicant
VERAXIS INT'L INC.
261 MADISON AVENUE
24TH FLOOR
new york,  NY  10016
Applicant Contact jules t mitchel
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
northbrook,  IL  60062
Correspondent Contact marc m mouser
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/24/2006
Decision Date 04/07/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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