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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 K000747
Device Name UNIVEC TWO PIECE SYRINGE
Applicant
UNIVEC, INC.
22 DUBON CT.
FARMINGDALE,  NY  11735
Applicant Contact S. LEVINSON
Correspondent
UNIVEC, INC.
22 DUBON CT.
FARMINGDALE,  NY  11735
Correspondent Contact S. LEVINSON
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/07/2000
Decision Date 06/08/2000
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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