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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 K934946
Device Name BILIBLANKET PLUS PHOTOTHERAPY SYSTEM
Applicant
Boc Health Care, Inc.
9065 Guilford Rd.
Columbia,  MD  21046
Applicant Contact ALBERTO F PROFUMO
Correspondent
Boc Health Care, Inc.
9065 Guilford Rd.
Columbia,  MD  21046
Correspondent Contact ALBERTO F PROFUMO
Regulation Number880.5700
Classification Product Code
LBI  
Date Received10/18/1993
Decision Date 07/05/1994
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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