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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K880180
Device Name STATFLO
Applicant
Imodex, Inc.
29777 Telegraph
Suite 2500
Southfield,  MI  48034
Applicant Contact SHELDON H DAVIS
Correspondent
Imodex, Inc.
29777 Telegraph
Suite 2500
Southfield,  MI  48034
Correspondent Contact SHELDON H DAVIS
Regulation Number870.4210
Classification Product Code
DWF  
Date Received01/13/1988
Decision Date 03/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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