MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS

Tester, Pulp

LIFE-TECH INTL., INC.

The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Model Sk-14 Starter Kit For Dental Iontophoresis.

Pre-market Notification Details

Device IDK872039
510k NumberK872039
Device Name:MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS
ClassificationTester, Pulp
Applicant LIFE-TECH INTL., INC. P.O. BOX 36221 Houston,  TX  77236 -6221
ContactAlfred C Coats,m.d.
CorrespondentAlfred C Coats,m.d.
LIFE-TECH INTL., INC. P.O. BOX 36221 Houston,  TX  77236 -6221
Product CodeEAT  
CFR Regulation Number872.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-27
Decision Date1987-11-13

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