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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 DRIVE, P.O. BOX 7550
MADISON,  WI  53707 -7550
Applicant Contact RAYMOND T RIDDLE
Correspondent
OHMEDA MEDICAL
OHMEDA DRIVE, P.O. BOX 7550
MADISON,  WI  53707 -7550
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
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