SteriStay— 510(k) K190027

Substantially Equivalent

Toul Meditech AB

FDA 510(k) clearance K190027 for SteriStay, Substantially Equivalent on 2019-05-10. Applicant: Toul Meditech AB. Device class: 2.

Clearance details

Applicant: Toul Meditech AB
Product code: Code ORC
Device class: Class 2
Regulation: 21 CFR 878.5070
Advisory panel: General, Plastic Surgery
Date received: 2019-01-07
Decision date: 2019-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vasteras, SE

Download summary PDF View on FDA.gov ↗

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