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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 K002381
Device Name PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES
Applicant
Pentaferte, S.R.L.
Zona Industriale
Campli (Teramo),  IT 64012
Applicant Contact VITTORIO SERVIDORI
Correspondent
Pentaferte, S.R.L.
Zona Industriale
Campli (Teramo),  IT 64012
Correspondent Contact VITTORIO SERVIDORI
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/04/2000
Decision Date 01/11/2001
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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