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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Incubator, Neonatal
510(k) Number K102226
Device Name DUAL INCU I
Applicant
ATOM MEDICAL CORPORATION
3-18-15 HONGO
BUNKYO-KU, TOKYO,  JP 113-0033
Applicant Contact TSUYOSHI SUGINO
Correspondent
ATOM MEDICAL CORPORATION
3-18-15 HONGO
BUNKYO-KU, TOKYO,  JP 113-0033
Correspondent Contact TSUYOSHI SUGINO
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received08/09/2010
Decision Date 01/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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