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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igm (Mu Chain Specific), Antigen, Antiserum, Control
510(k) Number K841992
Device Name MODIFICATION TO ACS CORONARY GUIDING
Applicant
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
Santa Clara,  CA  95054
Correspondent
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
Santa Clara,  CA  95054
Regulation Number866.5550
Classification Product Code
DAO  
Date Received04/25/1984
Decision Date 06/11/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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