BILLY BOY MALE LATEX CONDOM

Condom

MAPA GMBH

The following data is part of a premarket notification filed by Mapa Gmbh with the FDA for Billy Boy Male Latex Condom.

Pre-market Notification Details

Device IDK111093
510k NumberK111093
Device Name:BILLY BOY MALE LATEX CONDOM
ClassificationCondom
Applicant MAPA GMBH INDUSTRIESTRASSE 21-25 Zeven,  DE 27404
ContactGerman Frank
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-04-19
Decision Date2011-06-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850002174540 K111093 000
00850002174533 K111093 000

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