OPI BAND— 510(k) K001167

Substantially Equivalent

Orthomerica Products, Inc.

FDA 510(k) clearance K001167 for OPI BAND, Substantially Equivalent on 2000-07-07. Applicant: Orthomerica Products, Inc.. Device class: 2.

Clearance details

Applicant: Orthomerica Products, Inc.
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2000-04-10
Decision date: 2000-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.