TRUSTEX COLA FLAVORD CONDOM

Condom

LINE ONE LABORATORIES

The following data is part of a premarket notification filed by Line One Laboratories with the FDA for Trustex Cola Flavord Condom.

Pre-market Notification Details

Device IDK964598
510k NumberK964598
Device Name:TRUSTEX COLA FLAVORD CONDOM
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 Received1996-11-18
Decision Date1997-02-14

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