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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 K061856
Device Name V-2200 INFANT INCUBATOR
Applicant
Atom Medical, Inc.
35 Commerce Dr.
Ivyland,  PA  18974
Applicant Contact MARY STANIEWICZ
Correspondent
Atom Medical, Inc.
35 Commerce Dr.
Ivyland,  PA  18974
Correspondent Contact MARY STANIEWICZ
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received06/30/2006
Decision Date 09/28/2006
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
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