MONOTEX— 510(k) K140415

Substantially Equivalent

Riverpoint Medical

FDA 510(k) clearance K140415 for MONOTEX, Substantially Equivalent on 2014-03-26. Applicant: Riverpoint Medical. Device class: 2.

Clearance details

Applicant: Riverpoint Medical
Product code: Product code NBY
Device class: Class 2
Regulation: 21 CFR 878.5035
Advisory panel: General, Plastic Surgery
Date received: 2014-02-18
Decision date: 2014-03-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Portland, OR, 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.