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 |