The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Kendall Scd Express Kambia Thigh Length Tearaway Sleeve.
| Device ID | K040649 |
| 510k Number | K040649 |
| Device Name: | KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE |
| Classification | Sleeve, Limb, Compressible |
| 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 | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-11 |
| Decision Date | 2004-07-15 |
| Summary: | summary |