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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K893830
Device Name HEMO-ALERT
Applicant
Koregon Enterprise, Inc.
9735 SW Sunshine Ct.,
Suite 100
Beaverton,  OR  97005
Applicant Contact H. J PARK
Correspondent
Koregon Enterprise, Inc.
9735 SW Sunshine Ct.,
Suite 100
Beaverton,  OR  97005
Correspondent Contact H. J PARK
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/24/1989
Decision Date 10/12/1989
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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