MIS— 510(k) K923543

Substantially Equivalent

Ceram Optec, Inc.

FDA 510(k) clearance K923543 for MIS, Substantially Equivalent on 1993-03-29. Applicant: Ceram Optec, Inc.. Device class: 2.

Clearance details

Applicant: Ceram Optec, Inc.
Product code: Code HLJ
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1992-07-16
Decision date: 1993-03-29
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.