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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 K871177
Device Name NTH 101 UL
Applicant
ARAGONA MEDICAL, INC.
59 HERITAGE COURT
WOODCLIFF LAKE,  NJ  07675
Applicant Contact MICHAEL UGANDER
Correspondent
ARAGONA MEDICAL, INC.
59 HERITAGE COURT
WOODCLIFF LAKE,  NJ  07675
Correspondent Contact MICHAEL UGANDER
Regulation Number880.5130
Classification Product Code
FMT  
Date Received03/24/1987
Decision Date 10/09/1987
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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