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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered
510(k) Number K813029
Device Name VALVED SURGICAL ASPIRATORS
Applicant
IMEDIX
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
IMEDIX
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.6740
Classification Product Code
GCX  
Date Received10/28/1981
Decision Date 12/14/1981
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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