LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM

Condom, Synthetic

ANSELL HEALTHCARE PRODUCTS LLC

The following data is part of a premarket notification filed by Ansell Healthcare Products Llc with the FDA for Lifestyles Lubricated Polyisoprene Latex Male Condom.

Pre-market Notification Details

Device IDK070800
510k NumberK070800
Device Name:LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM
ClassificationCondom, Synthetic
Applicant ANSELL HEALTHCARE PRODUCTS LLC 1635 INDUSTRIAL RD. Dothan,  AL  36303
ContactLon D Mcilvain
CorrespondentLon D Mcilvain
ANSELL HEALTHCARE PRODUCTS LLC 1635 INDUSTRIAL RD. Dothan,  AL  36303
Product CodeMOL  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-23
Decision Date2008-03-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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30070907098012 K070800 000
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00070907271247 K070800 000
00070907271100 K070800 000
00070907271032 K070800 000
10070907271114 K070800 000

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