KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE— 510(k) K051805

Name: FDA 510(k) clearance K051805
Creator: U.S. Food and Drug Administration
Published: 2005-10-13

Substantially Equivalent

Tyco Healthcare/Kendall

FDA 510(k) clearance K051805 for KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE, Substantially Equivalent on 2005-10-13. Applicant: Tyco Healthcare/Kendall. Device class: 2.

Clearance details

Applicant: Tyco Healthcare/Kendall
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2005-07-05
Decision date: 2005-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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