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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 K941978
Device Name HIGH PRESSURE TUBING
Applicant
Abbott Laboratories
D-389, Ap-30
200 Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact FREDERIK A GUSTAFSON
Correspondent
Abbott Laboratories
D-389, Ap-30
200 Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact FREDERIK A GUSTAFSON
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/14/1994
Decision Date 12/13/1994
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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