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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 K921168
Device Name ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000
Applicant
Allen Medical Systems, Inc.
5198 Richmond Rd.
Bedford Heights,  OH  44146
Applicant Contact ANN LORDEMAN
Correspondent
Allen Medical Systems, Inc.
5198 Richmond Rd.
Bedford Heights,  OH  44146
Correspondent Contact ANN LORDEMAN
Regulation Number880.5420
Classification Product Code
KZD  
Date Received03/10/1992
Decision Date 04/21/1993
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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