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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 K882278
Device Name RESUSCITATION BAG CONTROLLER (RBC)
Applicant
PHYSICIAN ENGINEERED PRODUCTS, INC.
HCO6 BOX 17
PARK RAPIDS,  MN  56470
Applicant Contact ROSE, M.D.
Correspondent
PHYSICIAN ENGINEERED PRODUCTS, INC.
HCO6 BOX 17
PARK RAPIDS,  MN  56470
Correspondent Contact ROSE, M.D.
Regulation Number868.5915
Classification Product Code
BTM  
Date Received06/01/1988
Decision Date 06/16/1988
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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