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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, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K961552
Device Name CVP POLYURETHANE CATHETER
Applicant
Abbott Laboratories
Dept. 389, Ap30
Abbott Park,  IL  60064 -3537
Applicant Contact DAVID GUZEK
Correspondent
Abbott Laboratories
Dept. 389, Ap30
Abbott Park,  IL  60064 -3537
Correspondent Contact DAVID GUZEK
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/22/1996
Decision Date 02/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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