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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K002717
Device Name STERILE PISTON SYRINGE
Applicant
ABBOTT LABORATORIES
D-389, AP-30
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -3537
Applicant Contact THOMAS P SAMPONGA
Correspondent
ABBOTT LABORATORIES
D-389, AP-30
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -3537
Correspondent Contact THOMAS P SAMPONGA
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/31/2000
Decision Date 01/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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