STONY BROOK MODEL EECP-MC1

Device, Counter-pulsating, External

STONY BROOK TRADING AND DEVELOPMENT CORP.

The following data is part of a premarket notification filed by Stony Brook Trading And Development Corp. with the FDA for Stony Brook Model Eecp-mc1.

Pre-market Notification Details

Device IDK882401
510k NumberK882401
Device Name:STONY BROOK MODEL EECP-MC1
ClassificationDevice, Counter-pulsating, External
Applicant STONY BROOK TRADING AND DEVELOPMENT CORP. 25 ASHAROKEN AVE. Northport,  NY  11766
ContactHui, Phd
CorrespondentHui, Phd
STONY BROOK TRADING AND DEVELOPMENT CORP. 25 ASHAROKEN AVE. Northport,  NY  11766
Product CodeDRN  
CFR Regulation Number870.5225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-10
Decision Date1989-03-03

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