510(k) K002381

PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES by Pentaferte, S.R.L. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2001
Date Received
August 4, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type