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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 K792118
Device Name AIR-SHIELDS RESUSCITATORS
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 Number868.5915
Classification Product Code
BTM  
Date Received10/26/1979
Decision Date 11/13/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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