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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered
510(k) Number K924337
Device Name PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS
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
GCX  
Date Received08/27/1992
Decision Date 07/28/1993
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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