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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Neonatal Phototherapy
510(k) Number K040853
Device Name PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101
Applicant
INTERNATIONAL HOSPITAL SUPPLY CO.
AMSTEL 320-1
AMSTERDAM,  NL 1017AP
Applicant Contact ANGELIKA SCHERP
Correspondent
INTERNATIONAL HOSPITAL SUPPLY CO.
AMSTEL 320-1
AMSTERDAM,  NL 1017AP
Correspondent Contact ANGELIKA SCHERP
Regulation Number880.5700
Classification Product Code
LBI  
Date Received04/01/2004
Decision Date 06/21/2004
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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