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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 K944757
Device Name PISTON SYRINGES
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
2350 Qume Dr.
San Jose,  CA  95131
Applicant Contact KAREN ROSENCRANS
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
2350 Qume Dr.
San Jose,  CA  95131
Correspondent Contact KAREN ROSENCRANS
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/27/1994
Decision Date 01/11/1995
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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