LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT

Condom

SURETEX, LTD.

The following data is part of a premarket notification filed by Suretex, Ltd. with the FDA for Lifestyles, Contempo Or Private Label-male Latex Condom With Desensitizing Lubricant.

Pre-market Notification Details

Device IDK030176
510k NumberK030176
Device Name:LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT
ClassificationCondom
Applicant SURETEX, LTD. 1500 INDUSTRIAL RD. P.O. BOX 1252 Dothan,  AL  36302
ContactCynthia A Ingram
CorrespondentCynthia A Ingram
SURETEX, LTD. 1500 INDUSTRIAL RD. P.O. BOX 1252 Dothan,  AL  36302
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-17
Decision Date2003-04-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00070907209103 K030176 000
18859798101319 K030176 000
18859798101180 K030176 000
18859798104907 K030176 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.