ULTRA-CBX— 510(k) K991486

Substantially Equivalent

Medcanica, Inc.

FDA 510(k) clearance K991486 for ULTRA-CBX, Substantially Equivalent on 1999-11-05. Applicant: Medcanica, Inc.. Device class: 2.

Clearance details

Applicant: Medcanica, Inc.
Product code: Code DWZ
Device class: Class 2
Regulation: 21 CFR 870.4075
Advisory panel: Cardiovascular
Date received: 1999-04-28
Decision date: 1999-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.