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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 K800560
Device Name MX820-5 PRESSURE INFUSOR 500CC MX820-10
Applicant
Medex, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Medex, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5420
Classification Product Code
KZD  
Date Received03/12/1980
Decision Date 04/29/1980
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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