Iovera System— 510(k) K211334

Substantially Equivalent

Pacira Pharmaceuticals, Inc.

FDA 510(k) clearance K211334 for Iovera System, Substantially Equivalent on 2021-09-10. Applicant: Pacira Pharmaceuticals, Inc.. Device class: 2.

Clearance details

Applicant: Pacira Pharmaceuticals, Inc.
Product code: Code GXH
Device class: Class 2
Regulation: 21 CFR 882.4250
Advisory panel: Neurology
Date received: 2021-05-03
Decision date: 2021-09-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, 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.