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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 K050244
Device Name MALE NATURAL RUBBER LATEX CONDOM
Applicant
NRS GLOBAL PARTNERS
1219 LITTLE CREEK ROAD
DURHAM,  NC  27713
Applicant Contact ELI J CARTER
Correspondent
NRS GLOBAL PARTNERS
1219 LITTLE CREEK ROAD
DURHAM,  NC  27713
Correspondent Contact ELI J CARTER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received02/02/2005
Decision Date 04/08/2005
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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