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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 DRIVE
STEVENAGE HERTFORDSHIRE,  GB SGI 2DX
Applicant Contact NEIL R ARMSTRONG
Correspondent
SUMMIT MEDICAL LTD.
BUSINESS & TECHNOLOGY CENTRE
BESSEMER DRIVE
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
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