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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 K853926
Device Name NEOCARE MODEL 800 INFANT RADIANT WARMER
Applicant
DRAEGER MEDICAL, INC.
148 B. QUARRY RD.
TELFORD,  PA  18969
Applicant Contact EDWARD T GRIFFITH
Correspondent
DRAEGER MEDICAL, INC.
148 B. QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact EDWARD T GRIFFITH
Regulation Number880.5130
Classification Product Code
FMT  
Date Received09/24/1985
Decision Date 02/26/1986
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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