MRI NEURO DRAPE— 510(k) K091343

Substantially Equivalent

Surgivision, Inc.

FDA 510(k) clearance K091343 for MRI NEURO DRAPE, Substantially Equivalent on 2009-09-22. Applicant: Surgivision, Inc.. Device class: 2.

Clearance details

Applicant: Surgivision, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2009-05-06
Decision date: 2009-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, 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.