TACTYLON TM SURGICAL GLOVE

Surgeon's Gloves

TACTYL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Tactyl Technologies, Inc. with the FDA for Tactylon Tm Surgical Glove.

Pre-market Notification Details

Device IDK902831
510k NumberK902831
Device Name:TACTYLON TM SURGICAL GLOVE
ClassificationSurgeon's Gloves
Applicant TACTYL TECHNOLOGIES, INC. 2595 COMMERCE WAY Vista,  CA  92083
ContactBuddenhagen
CorrespondentBuddenhagen
TACTYL TECHNOLOGIES, INC. 2595 COMMERCE WAY Vista,  CA  92083
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-28
Decision Date1990-07-10

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