B&J DVT Calf/Thigh Garments, Models 801/830 Series— 510(k) K201532

Name: FDA 510(k) clearance K201532
Creator: U.S. Food and Drug Administration
Published: 2020-09-19

Substantially Equivalent

B&J Manufacturing , Ltd.

FDA 510(k) clearance K201532 for B&J DVT Calf/Thigh Garments, Models 801/830 Series, Substantially Equivalent on 2020-09-19. Applicant: B&J Manufacturing , Ltd.. Device class: 2.

Clearance details

Applicant: B&J Manufacturing , Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2020-06-08
Decision date: 2020-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.