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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 K080833
Device Name LOVE GUARD MALE LATEX CONDOM
Applicant
TIANJIN HUMAN-CARE LATEX CORPORATION
56 DANVILLE DRIVE
west windsor,  NJ  08550
Applicant Contact simon li
Correspondent
TIANJIN HUMAN-CARE LATEX CORPORATION
56 DANVILLE DRIVE
west windsor,  NJ  08550
Correspondent Contact simon li
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/25/2008
Decision Date 08/07/2008
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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