The following data is part of a premarket notification filed by Harvard Clinical Technology with the FDA for Harvard 2 Syringe Pump, Model 2001-001.
| Device ID | K050107 |
| 510k Number | K050107 |
| Device Name: | HARVARD 2 SYRINGE PUMP, MODEL 2001-001 |
| Classification | Pump, Infusion |
| Applicant | HARVARD CLINICAL TECHNOLOGY 22 PLEASANT ST. South Natick, MA 01760 |
| Contact | Eric J Flachbart |
| Correspondent | Eric J Flachbart HARVARD CLINICAL TECHNOLOGY 22 PLEASANT ST. South Natick, MA 01760 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-18 |
| Decision Date | 2005-02-11 |
| Summary: | summary |