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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 K852736
Device Name BAYLOR RAPID AUTOTRANSFUSION SYSTEM
Applicant
Cardio Systems, Inc.
1610 Woodstead Ct., Su 430
The Woodlands,  TX  77380
Applicant Contact DON E SPYRISON
Correspondent
Cardio Systems, Inc.
1610 Woodstead Ct., Su 430
The Woodlands,  TX  77380
Correspondent Contact DON E SPYRISON
Regulation Number868.5830
Classification Product Code
CAC  
Date Received05/08/1985
Decision Date 09/18/1985
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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