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510(k) K062143

Device
KOZY COMFORT INFANT POSITIONER
Applicant
Alfred E Mann Inst. For Biomedical Engineering
510(k) number
K062143
Product code
FRP
Decision
Substantially Equivalent (SESE)
Decision date
2006-10-24
Date received
2006-07-27
Regulation
880.5680
Classification name
Holder, Infant Position
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
ARMAN H NADERSHAHI
Address
1042 Downey Way, Drb 101 Los Angeles CA US 90089 90089

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K810609PEDIATRIC POSITION HOLDERKaye Products, Inc.1981-03-20