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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K843586
Device Name THORA-KLEX AUTOTRANSFUSION KIT
Applicant
C.R. Bard, Inc.
731 Central Ave.
Murray Hill,  NJ  07974
Applicant Contact CATHERINE V BEATH
Correspondent
C.R. Bard, Inc.
731 Central Ave.
Murray Hill,  NJ  07974
Correspondent Contact CATHERINE V BEATH
Date Received09/11/1984
Decision Date 10/25/1984
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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