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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 K962612
Device Name BILIBED PHOTOTHERAPY LAMP
Applicant
MEDELA, INC.
4610 PRIME PKWY.
P.O. BOX 660
MCHENRY,  IL  60050 -7005
Applicant Contact STEPHEN D SMITH
Correspondent
MEDELA, INC.
4610 PRIME PKWY.
P.O. BOX 660
MCHENRY,  IL  60050 -7005
Correspondent Contact STEPHEN D SMITH
Regulation Number880.5700
Classification Product Code
LBI  
Date Received07/03/1996
Decision Date 12/12/1996
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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