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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 K844106
Device Name SYRINGE W/NEEDLE COMBIN & SYRINGE ONLY
Applicant
Abco Dealers, Inc.
P.O. Box 17587
6637 N. Sidney Pl.
Milwaukee,  WI  53217
Applicant Contact PIYUSH M SHAH
Correspondent
Abco Dealers, Inc.
P.O. Box 17587
6637 N. Sidney Pl.
Milwaukee,  WI  53217
Correspondent Contact PIYUSH M SHAH
Regulation Number880.5860
Classification Product Code
FMF  
Date Received10/23/1984
Decision Date 01/14/1985
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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