CANDELA GUIDEWIRE— 510(k) K933268

Substantially Equivalent

Candela Laser Corp.

FDA 510(k) clearance K933268 for CANDELA GUIDEWIRE, Substantially Equivalent on 1994-02-10. Applicant: Candela Laser Corp.. Device class: 2.

Clearance details

Applicant: Candela Laser Corp.
Product code: Code NWU
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1993-07-06
Decision date: 1994-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayland, 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.