The following data is part of a premarket notification filed by Fabersanitas, S.a. with the FDA for Sterile Disposable Syringe(3 Pieces).
| Device ID | K852819 |
| 510k Number | K852819 |
| Device Name: | STERILE DISPOSABLE SYRINGE(3 PIECES) |
| Classification | Syringe, Piston |
| Applicant | FABERSANITAS, S.A. PRINCESA 15-50004 Zaragoza-spain, ES |
| Contact | Jalon Coromin |
| Correspondent | Jalon Coromin FABERSANITAS, S.A. PRINCESA 15-50004 Zaragoza-spain, ES |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-01 |
| Decision Date | 1985-09-20 |