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510(k) K981955

Device
MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS
Applicant
LS RUBBER SDN BHD
510(k) number
K981955
Product code
LTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1999-03-15
Date received
1998-06-04
Regulation
884.5310
Classification name
Condom With Nonoxynol-9
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RAJIL VOHRA
Address
11535 Park Woods Cir. Suite B Alpharetta GA US 30005 30005

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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