Lifestyles Zero Lubricated Latex Male Condom

Condom

ANSELL HEALTHCARE PRODUCTS, LLC

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

Pre-market Notification Details

Device IDK163107
510k NumberK163107
Device Name:Lifestyles Zero Lubricated Latex Male Condom
ClassificationCondom
Applicant ANSELL HEALTHCARE PRODUCTS, LLC 111 Wood Avenue South, Suite 210 Iselin,  NJ  08830
ContactRobert Mahler
CorrespondentRobert Mahler
ANSELL HEALTHCARE PRODUCTS, LLC 111 Wood Avenue South, Suite 210 Iselin,  NJ  08830
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-07
Decision Date2017-01-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30070907296371 K163107 000
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00070907207369 K163107 000
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80070907101106 K163107 000
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80070907703164 K163107 000
30070907202105 K163107 000
30070907230078 K163107 000
30070907230214 K163107 000
30070907201795 K163107 000
30070907220284 K163107 000
30070907296364 K163107 000
18859798101609 K163107 000

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