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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K770518
Device Name PIGGYBACK VENOSET W/0.22 FILTER
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/18/1977
Decision Date 04/29/1977
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
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