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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 K963679
Device Name LOVING SMARTER - SAFER SEX
Applicant
Loving Smarter, Inc.
P.O. Box 512
Winton,  NC  27986 -0512
Applicant Contact PATRICIA A EVERETT
Correspondent
Loving Smarter, Inc.
P.O. Box 512
Winton,  NC  27986 -0512
Correspondent Contact PATRICIA A EVERETT
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/13/1996
Decision Date 12/12/1996
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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