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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 K070416
Device Name NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP
Applicant
NEOFORCE GROUP, INC.
35 COMMERCE DR.
IVYLAND,  PA  18974
Applicant Contact MARY STANIEWICZ
Correspondent
NEOFORCE GROUP, INC.
35 COMMERCE DR.
IVYLAND,  PA  18974
Correspondent Contact MARY STANIEWICZ
Regulation Number868.5965
Classification Product Code
BYE  
Date Received02/12/2007
Decision Date 05/29/2007
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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