DUREX SYNTHETIC POLYISOPRENE MALE CONDOM

Condom, Synthetic

SSL AMERICAS, INC.

The following data is part of a premarket notification filed by Ssl Americas, Inc. with the FDA for Durex Synthetic Polyisoprene Male Condom.

Pre-market Notification Details

Device IDK072169
510k NumberK072169
Device Name:DUREX SYNTHETIC POLYISOPRENE MALE CONDOM
ClassificationCondom, Synthetic
Applicant SSL AMERICAS, INC. 3585 ENGINEERING DR. SUITE 200 Norcross,  GA  30092
ContactChris Robinson
CorrespondentChris Robinson
SSL AMERICAS, INC. 3585 ENGINEERING DR. SUITE 200 Norcross,  GA  30092
Product CodeMOL  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-06
Decision Date2008-06-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10302340894576 K072169 000
10302340894569 K072169 000
20302340894559 K072169 000
20302340908058 K072169 000
00302340894562 K072169 000

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