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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K890272
Device Name BAG DECANTER
Applicant
Superior Medical Products
P.O. Box 99
Mccaysville,  GA  30555
Applicant Contact COTTONE, JR
Correspondent
Superior Medical Products
P.O. Box 99
Mccaysville,  GA  30555
Correspondent Contact COTTONE, JR
Regulation Number880.5025
Classification Product Code
KPE  
Date Received01/18/1989
Decision Date 03/14/1989
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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