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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Separator, Automated, Blood Cell And Plasma, Therapeutic
510(k) Number K926409
Device Name PLASMA DISCARD BAGS
Applicant
Apheresis Technologies, Inc.
P.O. Box 2081
Palm Harbor,  FL  34682
Applicant Contact PATRICK J LAMB
Correspondent
Apheresis Technologies, Inc.
P.O. Box 2081
Palm Harbor,  FL  34682
Correspondent Contact PATRICK J LAMB
Classification Product Code
LKN  
Date Received12/21/1992
Decision Date 03/02/1993
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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