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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 K102710
Device Name NEO-SERVO I
Applicant
ATOM MEDICAL CORPORATION
24301 WOODSTAGE DRIVE
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
ATOM MEDICAL CORPORATION
24301 WOODSTAGE DRIVE
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received09/20/2010
Decision Date 12/22/2010
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
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