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510(k) K033163

Device
CAUTION CONDOMS
Applicant
RICHARD VAN HAUSSEN AMERICA, INC.
510(k) number
K033163
Product code
LTZ  
Decision
Substantially Equivalent (SESE)
Decision date
2004-04-27
Date received
2003-11-07
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
RICHARD QUAISON
Address
5777 W. Century Blvd. #1648 Los Angeles CA US 90045 90045

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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