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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 K881252
Device Name PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE
Applicant
Deknatel, Inc.
2300 Marcus Ave.
Lake Success,  NY  11042
Applicant Contact OROFINO
Correspondent
Deknatel, Inc.
2300 Marcus Ave.
Lake Success,  NY  11042
Correspondent Contact OROFINO
Regulation Number880.6740
Classification Product Code
GCX  
Date Received03/23/1988
Decision Date 06/17/1988
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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