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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 K060461
Device Name V-505 INFA WARMER
Applicant
ATOM MEDICAL INC
IWAKATA BLDG 3RD FLOOR
3-18-15 HUNGO
TOKOYO,  JP 1130033
Applicant Contact MARY STANIEWICZ
Correspondent
ATOM MEDICAL INC
IWAKATA BLDG 3RD FLOOR
3-18-15 HUNGO
TOKOYO,  JP 1130033
Correspondent Contact MARY STANIEWICZ
Regulation Number880.5130
Classification Product Code
FMT  
Date Received02/22/2006
Decision Date 04/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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