ORC ORACLE— 510(k) K853668

Substantially Equivalent

Optical Radiation Corp.

FDA 510(k) clearance K853668 for ORC ORACLE, Substantially Equivalent on 1985-10-15. Applicant: Optical Radiation Corp.. Device class: 1.

Clearance details

Applicant: Optical Radiation Corp.
Product code: Code HLQ
Device class: Class 1
Regulation: 21 CFR 886.1350
Advisory panel: Ophthalmic
Date received: 1985-09-03
Decision date: 1985-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Azusa, 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.