UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK)

Condom

UNIDUS CORP.

The following data is part of a premarket notification filed by Unidus Corp. with the FDA for Unidus Male Latex Condom (yellow, Pink, Green & Black).

Pre-market Notification Details

Device IDK023129
510k NumberK023129
Device Name:UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK)
ClassificationCondom
Applicant UNIDUS CORP. 1219 LITTLE CREEK RD. Durham,  NC  27713
ContactEli J Carter
CorrespondentEli J Carter
UNIDUS CORP. 1219 LITTLE CREEK RD. Durham,  NC  27713
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-19
Decision Date2002-12-13
Summary:summary

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