DANYANG HUAYI K2 AND K7 WHEELCHAIRS

Wheelchair, Mechanical

DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD

The following data is part of a premarket notification filed by Danyang Huayi Medical Supply & Equipment Co, Ltd with the FDA for Danyang Huayi K2 And K7 Wheelchairs.

Pre-market Notification Details

Device IDK080207
510k NumberK080207
Device Name:DANYANG HUAYI K2 AND K7 WHEELCHAIRS
ClassificationWheelchair, Mechanical
Applicant DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD 9109 COPENHAVER DRIVE Potomac,  MD  20854
ContactNorman F Estrin
CorrespondentNorman F Estrin
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD 9109 COPENHAVER DRIVE Potomac,  MD  20854
Product CodeIOR  
CFR Regulation Number890.3850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-28
Decision Date2008-03-12
Summary:summary

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