RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORANGE, PURPLE AND BLACK)

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 & Ria Color Condoms (red, Green, Blue, Orange, Purple And Black).

Pre-market Notification Details

Device IDK944786
510k NumberK944786
Device Name:RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORANGE, PURPLE AND BLACK)
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 Received1994-09-28
Decision Date1995-12-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850002174885 K944786 000
00850002174878 K944786 000
00850002174854 K944786 000
00850002174670 K944786 000

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