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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K963351
Device Name LIFESHIELD BLUNT CANNULA
Applicant
Abbott Laboratories
D-389, Ap-30
200 Abbott Park Rd.
Abbott Park,  IL  60064 -3537
Applicant Contact JILL N SACKETT
Correspondent
Abbott Laboratories
D-389, Ap-30
200 Abbott Park Rd.
Abbott Park,  IL  60064 -3537
Correspondent Contact JILL N SACKETT
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/26/1996
Decision Date 02/26/1997
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
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