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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 K861977
Device Name BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR
Applicant
Biomedical Dynamics, Inc.
3800 Multifoods Tower
33 S. Sixth St.
Minneapolis,  MN  55402
Applicant Contact JAMES W MOEN
Correspondent
Biomedical Dynamics, Inc.
3800 Multifoods Tower
33 S. Sixth St.
Minneapolis,  MN  55402
Correspondent Contact JAMES W MOEN
Regulation Number880.5420
Classification Product Code
KZD  
Date Received05/21/1986
Decision Date 07/15/1986
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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