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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name warmer, infant radiant
510(k) Number K850069
Device Name BORNING NEONATAL RESUSCITATOIN CENTER
Applicant
BORNING CORP.
SOUTH 161 ADAMS
SPOKANE,  WA  99204
Applicant Contact LOEL FENWICK
Correspondent
BORNING CORP.
SOUTH 161 ADAMS
SPOKANE,  WA  99204
Correspondent Contact LOEL FENWICK
Regulation Number880.5130
Classification Product Code
FMT  
Date Received01/03/1985
Decision Date 05/30/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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