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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 K903392
Device Name ELECTROMEDICS BT422-120 AND BT422-40
Applicant
Electromedics, Inc.
P.O. Box 3315
Englewood,  CO  80155
Applicant Contact HAROLD W BRYAN
Correspondent
Electromedics, Inc.
P.O. Box 3315
Englewood,  CO  80155
Correspondent Contact HAROLD W BRYAN
Regulation Number868.5830
Classification Product Code
CAC  
Date Received07/27/1990
Decision Date 09/06/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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