LIFESTYLES LIQUID PERSONAL LUBRICANT

Condom

ANSELL HEALTHCARE, INC.

The following data is part of a premarket notification filed by Ansell Healthcare, Inc. with the FDA for Lifestyles Liquid Personal Lubricant.

Pre-market Notification Details

Device IDK033076
510k NumberK033076
Device Name:LIFESTYLES LIQUID PERSONAL LUBRICANT
ClassificationCondom
Applicant ANSELL HEALTHCARE, INC. 1635 INDUSTRIAL RD. Dothan,  AL  36303
ContactLon D Mcilvain
CorrespondentLon D Mcilvain
ANSELL HEALTHCARE, INC. 1635 INDUSTRIAL RD. Dothan,  AL  36303
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-29
Decision Date2003-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40024291290481 K033076 000
10024291281419 K033076 000
10024291281389 K033076 000
10024291261015 K033076 000
00024291290483 K033076 000
00024291281412 K033076 000
00024291281382 K033076 000
00024291271925 K033076 000
00024291262831 K033076 000
00024291261018 K033076 000
10024291261190 K033076 000
00024291262824 K033076 000
00024291261193 K033076 000
20024291261012 K033076 000
20024291261029 K033076 000
30070907070001 K033076 000
30024291290484 K033076 000
20024291281416 K033076 000
20024291281386 K033076 000
20024291271929 K033076 000
20024291262835 K033076 000
20024291262828 K033076 000
20024291262811 K033076 000
20024291262804 K033076 000
20024291261197 K033076 000
20024291261043 K033076 000
20024291261036 K033076 000
18859798100329 K033076 000

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