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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microfilter, Blood Transfusion
510(k) Number K864636
Device Name ERYPUR B
Applicant
Organon Teknika Corp.
5516 Nicholson Ln.
Kensington,  TX  20895
Applicant Contact ROBERT D WURZEL
Correspondent
Organon Teknika Corp.
5516 Nicholson Ln.
Kensington,  TX  20895
Correspondent Contact ROBERT D WURZEL
Regulation Number880.5440
Classification Product Code
CAK  
Date Received11/26/1986
Decision Date 01/14/1987
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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