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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
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