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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Infant Position
510(k) Number K062143
Device Name KOZY COMFORT INFANT POSITIONER
Applicant
ALFRED E MANN INST. FOR BIOMEDICAL ENGINEERING
1042 DOWNEY WAY, DRB 101
LOS ANGELES,  CA  90089 -1112
Applicant Contact ARMAN H NADERSHAHI
Correspondent
ALFRED E MANN INST. FOR BIOMEDICAL ENGINEERING
1042 DOWNEY WAY, DRB 101
LOS ANGELES,  CA  90089 -1112
Correspondent Contact ARMAN H NADERSHAHI
Regulation Number880.5680
Classification Product Code
FRP  
Date Received07/27/2006
Decision Date 10/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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