TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR

Condom

LINE ONE LABORATORIES

The following data is part of a premarket notification filed by Line One Laboratories with the FDA for Trustex Mint Flavored Condom In Green Color, Impulse Mint Flavored Condom In Green Color.

Pre-market Notification Details

Device IDK991892
510k NumberK991892
Device Name:TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR
ClassificationCondom
Applicant LINE ONE LABORATORIES 1481 EAST 4TH ST. Los Angeles,  CA  90033
ContactRobert Gruber
CorrespondentRobert Gruber
LINE ONE LABORATORIES 1481 EAST 4TH ST. Los Angeles,  CA  90033
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-03
Decision Date1999-08-19

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