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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K102649
Device Name NEOPOP INFANT RESUSCITATOR WITH FLOW METER
Applicant
NEOFORCE GROUP, INC.
35 COMMERCE DR.
IVYLAND,  PA  18974
Applicant Contact MONICA FERRANTE
Correspondent
NEOFORCE GROUP, INC.
35 COMMERCE DR.
IVYLAND,  PA  18974
Correspondent Contact MONICA FERRANTE
Regulation Number868.5915
Classification Product Code
BTM  
Date Received09/14/2010
Decision Date 01/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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