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510(k) K062143

KOZY COMFORT INFANT POSITIONER by Alfred E Mann Inst. For Biomedical Engineering — Product Code FRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2006
Date Received
July 27, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Infant Position
Device Class
Class I
Regulation Number
880.5680
Review Panel
HO
Submission Type

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