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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 K853351
Device Name OHMEDA HEAT REFLECTING PATCH
Applicant
Ohmeda Medical
Ohmeda Dr.
P.O. Box 7550
Madison,  WI  53707
Applicant Contact RAYMOND T RIDDLE
Correspondent
Ohmeda Medical
Ohmeda Dr.
P.O. Box 7550
Madison,  WI  53707
Correspondent Contact RAYMOND T RIDDLE
Regulation Number880.5130
Classification Product Code
FMT  
Date Received08/12/1985
Decision Date 10/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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