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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 K884233
Device Name QUADROJECT(TM)
Applicant
ELLIS PHARMACEUTICAL CONSULTING, INC.
913 STATE RD.
PRINCETON,  NJ  08540 -1484
Applicant Contact LEVI ELLIS
Correspondent
ELLIS PHARMACEUTICAL CONSULTING, INC.
913 STATE RD.
PRINCETON,  NJ  08540 -1484
Correspondent Contact LEVI ELLIS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received10/07/1988
Decision Date 01/30/1989
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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