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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K801872
Device Name MODEL 86-01-1 260 SOLUTION ADMIN. SET
Applicant
Y
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
Y
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/05/1980
Decision Date 08/27/1980
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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