The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Kendall Lifetrace Umbilical Blood Collection Kit, Code 56501.
| Device ID | K032827 |
| 510k Number | K032827 |
| Device Name: | KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 |
| Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
| Applicant | TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Gail Christie |
| Correspondent | Gail Christie TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | KSR |
| CFR Regulation Number | 864.9100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-10 |
| Decision Date | 2003-12-08 |
| Summary: | summary |