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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bottle, Collection And Trap, Breathing System (Uncalibrated)
510(k) Number K790035
Device Name AMBU SUCTION BOOSTER
Applicant
Narco Air-Shields
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Narco Air-Shields
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6740
Classification Product Code
CBC  
Date Received01/05/1979
Decision Date 03/23/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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