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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K780503
Device Name INFUSION PUMP
Applicant
AIR-SHIELDS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AIR-SHIELDS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/29/1978
Decision Date 04/10/1978
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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