OPTIEAR— 510(k) K920322

Substantially Equivalent

Nankivell Industries, Inc.

FDA 510(k) clearance K920322 for OPTIEAR, Substantially Equivalent on 1992-04-23. Applicant: Nankivell Industries, Inc.. Device class: 1.

Clearance details

Applicant: Nankivell Industries, Inc.
Product code: Code ERA
Device class: Class 1
Regulation: 21 CFR 874.4770
Advisory panel: Ear, Nose, Throat
Date received: 1992-01-24
Decision date: 1992-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Fernando, CA, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.