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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 K953489
Device Name DRAGER INFANT RADIANT WARMERN RH600
Applicant
DRAGER, INC.
4101-100 PLEASANT VALLEY RD.
CHANTILLY,  VA  22021
Applicant Contact HARALD KNEUER
Correspondent
DRAGER, INC.
4101-100 PLEASANT VALLEY RD.
CHANTILLY,  VA  22021
Correspondent Contact HARALD KNEUER
Regulation Number880.5130
Classification Product Code
FMT  
Date Received07/25/1995
Decision Date 02/09/1996
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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