DENPAX

Unit, Suction Operatory

NISSHO IWAI AMERICAN CORP.

The following data is part of a premarket notification filed by Nissho Iwai American Corp. with the FDA for Denpax.

Pre-market Notification Details

Device IDK860058
510k NumberK860058
Device Name:DENPAX
ClassificationUnit, Suction Operatory
Applicant NISSHO IWAI AMERICAN CORP. 1211 AVE. OF THE AMERICAS New York,  NY  10036
ContactLiu
CorrespondentLiu
NISSHO IWAI AMERICAN CORP. 1211 AVE. OF THE AMERICAS New York,  NY  10036
Product CodeEBR  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-06
Decision Date1986-03-12

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