LIFESTYLES XTRA PLEASURE

Condom

ANSELL, INC.

The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Lifestyles Xtra Pleasure.

Pre-market Notification Details

Device IDK983518
510k NumberK983518
Device Name:LIFESTYLES XTRA PLEASURE
ClassificationCondom
Applicant ANSELL, INC. 1500 INDUSTRIAL RD. Dothan,  AL  36303
ContactLon Mcilvain
CorrespondentLon Mcilvain
ANSELL, INC. 1500 INDUSTRIAL RD. Dothan,  AL  36303
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-07
Decision Date1999-07-06
Summary:summary

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