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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 K021809
Device Name V-2100G ADVANCED INFANT INCUBATOR
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 Number880.5400
Classification Product Code
FMZ  
Date Received06/03/2002
Decision Date 07/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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