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.

Clearance details

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

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