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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 K884133
Device Name PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP
Applicant
PREEMICARE CORP.
3300 WALNUT BEND LN.
HOUSTON,  TX  77042
Applicant Contact CHARLES S BOYD
Correspondent
PREEMICARE CORP.
3300 WALNUT BEND LN.
HOUSTON,  TX  77042
Correspondent Contact CHARLES S BOYD
Regulation Number880.5700
Classification Product Code
LBI  
Date Received09/30/1988
Decision Date 03/08/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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