The following data is part of a premarket notification filed by Tyco Healthcare/kendall with the FDA for Kendall Monoject Pre-fill Advanced 0.9%sodium Chloride Flush Syringes For Sterile Delivery.
| Device ID | K060339 |
| 510k Number | K060339 |
| Device Name: | KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY |
| Classification | Saline, Vascular Access Flush |
| Applicant | TYCO HEALTHCARE/KENDALL 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Contact | Bridget Gardner |
| Correspondent | Bridget Gardner TYCO HEALTHCARE/KENDALL 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-10 |
| Decision Date | 2006-04-28 |
| Summary: | summary |