The following data is part of a premarket notification filed by Artsana S.p.a. with the FDA for Artsana Piston And Insulin Syringes.
Device ID | K052667 |
510k Number | K052667 |
Device Name: | ARTSANA PISTON AND INSULIN SYRINGES |
Classification | Syringe, Piston |
Applicant | ARTSANA S.P.A. 22411 60TH STREET Bristol, WI 53104 |
Contact | Lara N Simmons |
Correspondent | Lara N Simmons ARTSANA S.P.A. 22411 60TH STREET Bristol, WI 53104 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-27 |
Decision Date | 2005-11-25 |