FIBRELIGHT NASAL SPECULA— 510(k) K853588

Substantially Equivalent

Downs Surgical , Ltd.

FDA 510(k) clearance K853588 for FIBRELIGHT NASAL SPECULA, Substantially Equivalent on 1985-12-18. Applicant: Downs Surgical , Ltd.. Device class: 1.

Clearance details

Applicant: Downs Surgical , Ltd.
Product code: Code EPY
Device class: Class 1
Regulation: 21 CFR 878.1800
Advisory panel: General, Plastic Surgery
Date received: 1985-08-27
Decision date: 1985-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, MA, US

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K900608 — SHEPPERD LUMBAR DISCECTOMY SYSTEM1990-10-22

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