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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 K855054
Device Name THE WOOD PUMP 'OLE RED'
Applicant
T.C. Retigo, Inc.
400 L. P. Mann Dr.
Marion,  AR  72364
Applicant Contact ANDY WOOD
Correspondent
T.C. Retigo, Inc.
400 L. P. Mann Dr.
Marion,  AR  72364
Correspondent Contact ANDY WOOD
Regulation Number880.5420
Classification Product Code
KZD  
Date Received12/17/1985
Decision Date 03/18/1986
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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