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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Infusor, Pressure, For I.V. Bags
510(k) Number K810954
Device Name NORFOLK/NORWICH PRESSURE INFUSION BOX
Applicant
Medical Innovations Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medical Innovations Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5420
Classification Product Code
KZD  
Date Received04/07/1981
Decision Date 04/21/1981
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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