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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 K051288
Device Name VIELLE LUBRICANT
Applicant
CST MEDICAL LIMITED
1676 VILLAGE GREEN
SUITE A
crofton,  MD  21114
Applicant Contact christian smith
Correspondent
CST MEDICAL LIMITED
1676 VILLAGE GREEN
SUITE A
crofton,  MD  21114
Correspondent Contact christian smith
Regulation Number884.5300
Classification Product Code
HIS  
Subsequent Product Code
KMJ  
Date Received05/18/2005
Decision Date 02/03/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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