The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Monoject Prefill Heparin Lock Flush Syringe.
| Device ID | K013556 |
| 510k Number | K013556 |
| Device Name: | MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | David A Olson |
| Correspondent | David A Olson TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-25 |
| Decision Date | 2001-12-31 |
| Summary: | summary |