UNDUS MALE LATEX CONDOM (WITH FLAVORING)

Condom

UNIDUS CORP.

The following data is part of a premarket notification filed by Unidus Corp. with the FDA for Undus Male Latex Condom (with Flavoring).

Pre-market Notification Details

Device IDK023176
510k NumberK023176
Device Name:UNDUS MALE LATEX CONDOM (WITH FLAVORING)
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 Received2002-09-23
Decision Date2002-12-13
Summary:summary

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