The following data is part of a premarket notification filed by Tyco Healthcare/kendall with the FDA for Kendall Scd Sleeves (extra Large Knee, Extra Large Thigh), Kendall Scd Lexpres Sleeves (extra Large Knee, Extra Large.
| Device ID | K051805 |
| 510k Number | K051805 |
| Device Name: | KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE |
| Classification | Sleeve, Limb, Compressible |
| 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 | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-05 |
| Decision Date | 2005-10-13 |
| Summary: | summary |