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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 K951592
Device Name BETATRANS I AND II
Applicant
Duxbury Scientific, Inc.
183 Whiting St.
Hingham,  MA  02043
Applicant Contact ROBERT M ENGLER
Correspondent
Duxbury Scientific, Inc.
183 Whiting St.
Hingham,  MA  02043
Correspondent Contact ROBERT M ENGLER
Regulation Number868.5830
Classification Product Code
CAC  
Date Received04/06/1995
Decision Date 03/04/1996
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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