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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 K021186
Device Name CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG,
Applicant
Condomi Erfert Prodoktionsgesellschaft Mbh
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact CAROLANN KOTULA
Correspondent
Condomi Erfert Prodoktionsgesellschaft Mbh
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact CAROLANN KOTULA
Regulation Number884.5300
Classification Product Code
HIS  
Subsequent Product Code
LTZ  
Date Received04/15/2002
Decision Date 10/25/2002
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
Predetermined Change
Control Plan Authorized		 No
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