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510(k) K001377

Device
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
Applicant
PLEASURE LATEX PRODUCTS SDN. BHD.
510(k) number
K001377
Product code
LTZ  
Decision
Substantially Equivalent (SESE)
Decision date
2000-06-08
Date received
2000-05-01
Regulation
884.5310
Classification name
Condom With Nonoxynol-9
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Abbreviated
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
LIM KOI-YONG
Address
Lot 1365, 17th Miles, Jalan Sungai Sembilang Jeram, Selangor Darul Ehsan MY 45800 45800

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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