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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 K831849
Device Name PLEURAL DRAINAGE SYS #PDS-100-4
Applicant
AMERICAN BENTLEY
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AMERICAN BENTLEY
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5830
Classification Product Code
CAC  
Date Received06/08/1983
Decision Date 12/29/1983
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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