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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 K802707
Device Name DRAGER PEEP CONTROL SYSTEM
Applicant
DRAEGER MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DRAEGER MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5965
Classification Product Code
BYE  
Date Received10/31/1980
Decision Date 11/12/1980
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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