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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 K860306
Device Name BT-795/P AUTOMATED AUTOTRANS
Applicant
Electromedics, Inc.
P.O. Box 3315
Englewood,  CO  80155
Applicant Contact GARY D REEDER
Correspondent
Electromedics, Inc.
P.O. Box 3315
Englewood,  CO  80155
Correspondent Contact GARY D REEDER
Regulation Number868.5830
Classification Product Code
CAC  
Date Received01/28/1986
Decision Date 03/06/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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