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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 K933700
Device Name DYE MANAGEMENT SYSTEM
Applicant
ABBOTT LABORATORIES
D-389, AP-30
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -3537
Applicant Contact FREDERICK A GUSTAFSON
Correspondent
ABBOTT LABORATORIES
D-389, AP-30
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -3537
Correspondent Contact FREDERICK A GUSTAFSON
Regulation Number870.1200
Classification Product Code
DQO  
Date Received07/29/1993
Decision Date 11/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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