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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name attachment, breathing, positive end expiratory pressure
510(k) Number K103833
Device Name NEOPIP PATIENT CIRCUIT WITH PEEP
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 Number868.5965
Classification Product Code
BYE  
Date Received12/30/2010
Decision Date 04/20/2011
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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