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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 K896134
Device Name ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.
Applicant
Goosen Enterprises, Inc.
P.O. Box 10
Goldenrod,  FL  32733
Applicant Contact CARL C GOOSEN
Correspondent
Goosen Enterprises, Inc.
P.O. Box 10
Goldenrod,  FL  32733
Correspondent Contact CARL C GOOSEN
Regulation Number880.6740
Classification Product Code
GCX  
Date Received10/24/1989
Decision Date 08/30/1990
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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