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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 K895894
Device Name PROFIL CONDOM (RUBBER LATEX)
Applicant
RFSU
ROSENLUNDSGATAN 13
BOX 17006 104 62
STOCKHOLM, SWEDEN,  SE
Applicant Contact NILS DIDING
Correspondent
RFSU
ROSENLUNDSGATAN 13
BOX 17006 104 62
STOCKHOLM, SWEDEN,  SE
Correspondent Contact NILS DIDING
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/05/1989
Decision Date 12/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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