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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 K110550
Device Name BRIGHT EMBRACE MODEL SBL60
Applicant
Physician Engineered Products, Inc.
103 Smith St.
Fryeburg,  ME  04037
Applicant Contact ROBERT ROSE
Correspondent
Physician Engineered Products, Inc.
103 Smith St.
Fryeburg,  ME  04037
Correspondent Contact ROBERT ROSE
Regulation Number880.5700
Classification Product Code
LBI  
Date Received02/25/2011
Decision Date 02/03/2012
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
Recalls CDRH Recalls
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