HEMEDEX FIXATION DEVICE— 510(k) K032127

Substantially Equivalent

Hemedex Incorporated

FDA 510(k) clearance K032127 for HEMEDEX FIXATION DEVICE, Substantially Equivalent on 2003-12-30. Applicant: Hemedex Incorporated. Device class: 2.

Clearance details

Applicant: Hemedex Incorporated
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2003-07-10
Decision date: 2003-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkonton, MA, US

Download summary PDF View on FDA.gov ↗

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