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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Extra-Luminal
510(k) Number K961137
Device Name ATI PLASMA PUMP (PP-04)
Applicant
Apheresis Technologies, Inc.
612 Florida Ave.
Palm Harbor,  FL  34683
Applicant Contact JOHN B CORNISH
Correspondent
Apheresis Technologies, Inc.
612 Florida Ave.
Palm Harbor,  FL  34683
Correspondent Contact JOHN B CORNISH
Regulation Number876.5820
Classification Product Code
FIR  
Date Received03/21/1996
Decision Date 06/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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