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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 K905448
Device Name THORA-KLEX CHEST DRAINAGE UNIT
Applicant
Davol, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston,  RI  02920
Applicant Contact LEO L BASTA
Correspondent
Davol, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston,  RI  02920
Correspondent Contact LEO L BASTA
Regulation Number880.6740
Classification Product Code
GCX  
Date Received12/05/1990
Decision Date 03/27/1991
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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