RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE

Condom

LINE ONE LABORATORIES & TRADING CO.

The following data is part of a premarket notification filed by Line One Laboratories & Trading Co. with the FDA for Ria Latex Condom With Spermicide, Ria Color Condom With Spermicide.

Pre-market Notification Details

Device IDK945930
510k NumberK945930
Device Name:RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE
ClassificationCondom
Applicant LINE ONE LABORATORIES & TRADING CO. P.O. BOX 861941 Los Angeles,  CA  90086
ContactBudiman Lee
CorrespondentBudiman Lee
LINE ONE LABORATORIES & TRADING CO. P.O. BOX 861941 Los Angeles,  CA  90086
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-05
Decision Date1995-12-19

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