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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 K880162
Device Name PLEUR-EVAC--A-5002 CHEST DRAINAGE SYSTEM W/AUTO
Applicant
Deknatel, Inc.
2300 Marcus Ave.
Lake Success,  NY  11042
Applicant Contact RICHARD J LARKIN
Correspondent
Deknatel, Inc.
2300 Marcus Ave.
Lake Success,  NY  11042
Correspondent Contact RICHARD J LARKIN
Regulation Number868.5830
Classification Product Code
CAC  
Date Received01/13/1988
Decision Date 03/21/1988
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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