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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 K984589
Device Name PHOTOTHERAPY LAMP
Applicant
Medela, Inc.
4610 Prime Pkwy.
P.O. Box 660
Mchenry,  IL  60050
Applicant Contact STEPHEN D SMITH
Correspondent
Medela, Inc.
4610 Prime Pkwy.
P.O. Box 660
Mchenry,  IL  60050
Correspondent Contact STEPHEN D SMITH
Regulation Number880.5700
Classification Product Code
LBI  
Date Received12/24/1998
Decision Date 04/20/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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