POWERPRESS UNIT

Sleeve, Limb, Compressible

HANURI DISTRIBUTION, INC

The following data is part of a premarket notification filed by Hanuri Distribution, Inc with the FDA for Powerpress Unit.

Pre-market Notification Details

Device IDK110276
510k NumberK110276
Device Name:POWERPRESS UNIT
ClassificationSleeve, Limb, Compressible
Applicant HANURI DISTRIBUTION, INC 9601 OWENSMOUTH AVENUE # 8 Chatsworth,  CA  91311
ContactJung Hyun Moon
CorrespondentJung Hyun Moon
HANURI DISTRIBUTION, INC 9601 OWENSMOUTH AVENUE # 8 Chatsworth,  CA  91311
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-31
Decision Date2011-11-09
Summary:summary

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