The following data is part of a premarket notification filed by Surgimed, Inc. with the FDA for Forsure Disposable Syringe With Needle, Model 1cc, 3c, 5cc, 10cc, 20cc, 50cc.
| Device ID | K062753 |
| 510k Number | K062753 |
| Device Name: | FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC |
| Classification | Syringe, Piston |
| Applicant | SURGIMED, INC. 1303 NW 78 AVE Miami, FL 33126 |
| Contact | Fernando Lavoi |
| Correspondent | Fernando Lavoi SURGIMED, INC. 1303 NW 78 AVE Miami, FL 33126 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-14 |
| Decision Date | 2007-02-08 |
| Summary: | summary |