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 |