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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 K881350
Device Name CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM
Applicant
STRYKER CORP.
420 alcott st.
kalamazoo,  MI  49001
Applicant Contact harmon woodworth
Correspondent
STRYKER CORP.
420 alcott st.
kalamazoo,  MI  49001
Correspodent Contact harmon woodworth
Regulation Number868.5830
Classification Product Code
CAC  
Date Received03/30/1988
Decision Date 09/30/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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