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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 K872861
Device Name LOVIEL CONDOM
Applicant
LLOVIEL MARKETING CORP.
10375 WEST 70TH ST.
EDEN PRAIRIE,  MN  55344
Applicant Contact KATHLEEN G KIM
Correspondent
LLOVIEL MARKETING CORP.
10375 WEST 70TH ST.
EDEN PRAIRIE,  MN  55344
Correspondent Contact KATHLEEN G KIM
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/21/1987
Decision Date 12/11/1987
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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