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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bottle, Collection, Vacuum
510(k) Number K905768
Device Name PLEUR-EVAC CHEST DRAINAGE SYSTEMS
Applicant
Deknatel, Inc.
Kilometer 9 Carretera
San Jose-Heredia,  CR
Applicant Contact MICHAEL SANTALUCIA
Correspondent
Deknatel, Inc.
Kilometer 9 Carretera
San Jose-Heredia,  CR
Correspondent Contact MICHAEL SANTALUCIA
Regulation Number880.6740
Classification Product Code
KDQ  
Date Received12/27/1990
Decision Date 02/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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