CUROS TIP— 510(k) K121171

Substantially Equivalent

Ivera Medical, Inc.

FDA 510(k) clearance K121171 for CUROS TIP, Substantially Equivalent on 2012-11-26. Applicant: Ivera Medical, Inc.. Device class: 2.

Clearance details

Applicant: Ivera Medical, Inc.
Product code: Code QBP
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2012-04-17
Decision date: 2012-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, 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.