PROBLOC INSULATED NEEDLES

Electrode, Needle

LIFE-TECH INTL., INC.

The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Probloc Insulated Needles.

Pre-market Notification Details

Device IDK926349
510k NumberK926349
Device Name:PROBLOC INSULATED NEEDLES
ClassificationElectrode, Needle
Applicant LIFE-TECH INTL., INC. P.O. BOX 36221 Houston,  TX  77236 -6221
ContactAlfred C Coats
CorrespondentAlfred C Coats
LIFE-TECH INTL., INC. P.O. BOX 36221 Houston,  TX  77236 -6221
Product CodeGXZ  
CFR Regulation Number882.1350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-17
Decision Date1993-07-29

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