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510(k) K010178

Device
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
Applicant
INNOLATEX SDN. BHD
510(k) number
K010178
Product code
LTZ  
Decision
Substantially Equivalent (SESE)
Decision date
2001-04-27
Date received
2001-01-19
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
CHANG AU-KAU
Address
# 16, Jalan Bulan U5/5, Bandar Pinggiran Subang Shah Alam, Selangor D.E. MY 40150 40150

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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