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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 K033166
Device Name KACEY INSULIN SYRINGE
Applicant
Kacey, Inc.
715 Buckeye Ter.
Rock Hill,  SC  29732
Applicant Contact CHARLES F NEILSON, PHD
Correspondent
Kacey, Inc.
715 Buckeye Ter.
Rock Hill,  SC  29732
Correspondent Contact CHARLES F NEILSON, PHD
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/30/2003
Decision Date 12/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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