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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 K812292
Device Name AUTOTRANS BT795
Applicant
ELECTROMEDICS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ELECTROMEDICS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5830
Classification Product Code
CAC  
Date Received08/13/1981
Decision Date 10/23/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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