TACTYLON(TM) CONDOM

Condom

TACTYL TECHNOLOGIES, INC.

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

Pre-market Notification Details

Device IDK911431
510k NumberK911431
Device Name:TACTYLON(TM) CONDOM
ClassificationCondom
Applicant TACTYL TECHNOLOGIES, INC. 2595 COMMERCE WAY Vista,  CA  92083
ContactBuddenhagen
CorrespondentBuddenhagen
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 Received1991-04-02
Decision Date1994-12-27

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