LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM

Condom

ANSELL HEALTHCARE, INC.

The following data is part of a premarket notification filed by Ansell Healthcare, Inc. with the FDA for Lifestyles, Contempo Or Private Label Large Condom.

Pre-market Notification Details

Device IDK001883
510k NumberK001883
Device Name:LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
ClassificationCondom
Applicant ANSELL HEALTHCARE, INC. 1500 INDUSTRIAL RD. P.O. BOX 1252 Dothan,  AL  36302
ContactLon D Mcilvain
CorrespondentLon D Mcilvain
ANSELL HEALTHCARE, INC. 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 Received2000-06-21
Decision Date2000-07-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00813356000187 K001883 000
18859798100497 K001883 000
18859798100084 K001883 000
30070907098012 K001883 000
00070907298107 K001883 000
00792554643016 K001883 000
00792554903028 K001883 000
10070907000356 K001883 000
10070907202125 K001883 000
30070907230085 K001883 000
30070907298580 K001883 000
30070907230412 K001883 000
30070907230429 K001883 000
30070907098005 K001883 000
00850002174489 K001883 000
00850002174496 K001883 000
00070907098035 K001883 000
00070907270981 K001883 000
18859798101562 K001883 000

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