The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Auto-fill Syringe Kit, Model 7600.
| Device ID | K063851 |
| 510k Number | K063851 |
| Device Name: | AUTO-FILL SYRINGE KIT, MODEL 7600 |
| Classification | Syringe, Piston |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Patrice Stromberg |
| Correspondent | Patrice Stromberg VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-28 |
| Decision Date | 2007-01-26 |
| Summary: | summary |