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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K802800
Device Name NARCO AIR-SHEILDS SYS. 100 MONITOR SYS
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 Number870.1435
Classification Product Code
DXG  
Date Received11/06/1980
Decision Date 11/24/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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