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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 K865012
Device Name YSI MODEL 801
Applicant
Yellow Springs Instrument Co., Inc.
1725 Brannum Ln.
Yellow Springs,  OH  45387
Applicant Contact ERNST SOSTMAN
Correspondent
Yellow Springs Instrument Co., Inc.
1725 Brannum Ln.
Yellow Springs,  OH  45387
Correspondent Contact ERNST SOSTMAN
Regulation Number880.5130
Classification Product Code
FMT  
Date Received12/23/1986
Decision Date 03/04/1987
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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