LOVE GUARD MALE LATEX CONDOM


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

Correspodent Contact simon li
Regulation Number 884.5300
Classification Product Code
HIS  
Date Received 03/25/2008
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