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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory Equipment, Cardiopulmonary Bypass
510(k) Number K934782
Device Name AMMEX TUBING ORGANIZER
Applicant
Ammex Cardiopulmonary Corp.
221 Norfolk
Suite 508
Houston,  TX  77098
Applicant Contact HILLARD E MILLER III
Correspondent
Ammex Cardiopulmonary Corp.
221 Norfolk
Suite 508
Houston,  TX  77098
Correspondent Contact HILLARD E MILLER III
Regulation Number870.4200
Classification Product Code
KRI  
Date Received10/06/1993
Decision Date 11/18/1993
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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