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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 K892940
Device Name PRECIOUS LITE MODEL 4224
Applicant
E & B Technologies, Inc.
4035 Oceanside Blvd-C-16
P.O. Box 6377
Oceanside,  CA  92056
Applicant Contact JOHN ERICKSON
Correspondent
E & B Technologies, Inc.
4035 Oceanside Blvd-C-16
P.O. Box 6377
Oceanside,  CA  92056
Correspondent Contact JOHN ERICKSON
Regulation Number880.5700
Classification Product Code
LBI  
Date Received04/21/1989
Decision Date 08/03/1989
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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