SWABCAP— 510(k) K083508

Substantially Equivalent

Excelsior Medical Corp.

FDA 510(k) clearance K083508 for SWABCAP, Substantially Equivalent on 2009-04-28. Applicant: Excelsior Medical Corp.. Device class: 2.

Clearance details

Applicant: Excelsior Medical Corp.
Product code: Code QBP
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2008-11-26
Decision date: 2009-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundas, On, CA

Download summary PDF View on FDA.gov ↗

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