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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 K863706
Device Name LOVESAFE CONTRACEPTIVE CONDOMS, TYPE NL-50
Applicant
MANEXIM MULTICORP, LTD.
1625 SISMET ROAD #15
MISSISSAUGA, ONTARIO,
CANADA LAW1V6,  CA
Applicant Contact LAVIAN
Correspondent
MANEXIM MULTICORP, LTD.
1625 SISMET ROAD #15
MISSISSAUGA, ONTARIO,
CANADA LAW1V6,  CA
Correspondent Contact LAVIAN
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/23/1986
Decision Date 09/26/1986
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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