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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Autotransfusion
510(k) Number K022489
Device Name SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514
Applicant
Summit Medical , Ltd.
Business & Technology Centre
Bessemer Dr.
Stevenage Hertfordshire,  GB SGI 2DX
Applicant Contact NEIL R ARMSTRONG
Correspondent
Summit Medical , Ltd.
Business & Technology Centre
Bessemer Dr.
Stevenage Hertfordshire,  GB SGI 2DX
Correspondent Contact NEIL R ARMSTRONG
Regulation Number868.5830
Classification Product Code
CAC  
Date Received07/29/2002
Decision Date 10/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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