LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE 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 Glycerine Lubricant.

Pre-market Notification Details

Device IDK010371
510k NumberK010371
Device Name:LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT
ClassificationCondom
Applicant SURETEX, LTD. 1500 INDUSTRIAL RD. P.O. BOX 1252 Dothan,  AL  36302
ContactLon D Mcilvain
CorrespondentLon D Mcilvain
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 Received2001-02-07
Decision Date2001-04-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30070907298559 K010371 000
80070907692574 K010371 000
18859798101043 K010371 000

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