LUBRICATED CONDOM

Condom

TACTYL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Tactyl Technologies, Inc. with the FDA for Lubricated Condom.

Pre-market Notification Details

Device IDK953583
510k NumberK953583
Device Name:LUBRICATED CONDOM
ClassificationCondom
Applicant TACTYL TECHNOLOGIES, INC. 2595 COMMERCE WAY Vista,  CA  92083
ContactJorge Haider
CorrespondentJorge Haider
TACTYL TECHNOLOGIES, INC. 2595 COMMERCE WAY Vista,  CA  92083
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-01
Decision Date1996-01-26

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