FDA.report

510(k) K053574

Device
MEDLINE PEDIATRIC WHEELCHAIRS
Applicant
MEDLINE INDUSTRIES, INC.
510(k) number
K053574
Product code
IOR  
Decision
Substantially Equivalent (SESE)
Decision date
2006-01-25
Date received
2005-12-22
Regulation
890.3850
Classification name
Wheelchair, Mechanical
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
LARA N SIMMONS
Address
One Medline Pl. Mundelein IL US 60060 60060

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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