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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 K002355
Device Name ATOM INFA WARMER V-505
Applicant
ATOM MEDICAL CORP.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact SHEILA HEMEON-HEYER
Correspondent
ATOM MEDICAL CORP.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact SHEILA HEMEON-HEYER
Regulation Number880.5130
Classification Product Code
FMT  
Date Received08/02/2000
Decision Date 10/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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