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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K843737
Device Name PNEUPAC INSTANT ACTION VENTILATOR/RESUS
Applicant
PNEU PAC, LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PNEU PAC, LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/25/1984
Decision Date 10/04/1984
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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