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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 K843223
Device Name FLOW CONTROLLER
Applicant
PRECISION MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PRECISION MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5915
Classification Product Code
BTM  
Date Received08/16/1984
Decision Date 09/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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