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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Disposable
510(k) Number K780880
Device Name Y-TYPE BLOOD SET
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 Number878.4800
Classification Product Code
KDC  
Date Received05/30/1978
Decision Date 06/30/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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