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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 K802231
Device Name AIR VIVA II
Applicant
GENERAL MEDICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GENERAL MEDICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5915
Classification Product Code
BTM  
Date Received09/15/1980
Decision Date 10/10/1980
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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