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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 K954150
Device Name VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Applicant
GREEN FIELD MEDICAL SOURCING, INC.
910 BOSTON TURNPIKE RD.
SHREWSBURY,  MA  01545
Applicant Contact BRIAN SWANSON
Correspondent
GREEN FIELD MEDICAL SOURCING, INC.
910 BOSTON TURNPIKE RD.
SHREWSBURY,  MA  01545
Correspondent Contact BRIAN SWANSON
Regulation Number868.5915
Classification Product Code
BTM  
Date Received09/05/1995
Decision Date 12/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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