510(k) K052667

ARTSANA PISTON AND INSULIN SYRINGES by Artsana S.P.A — Product Code FMF

K052667 is an FDA 510(k) premarket notification submitted by Artsana S.P.A for the device "ARTSANA PISTON AND INSULIN SYRINGES". The FDA issued a decision of Substantially Equivalent on Nov 25, 2005. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Artsana S.P.A has 2 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 25, 2005
Date Received
Sep 27, 2005
Clearance Type
Abbreviated
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
510(k)

Source: FDA 510(k) database entry for K052667. Report a data issue: hello@regdatalab.com.